Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of prostate cancer.

LEARNING OBJECTIVES

• Evaluate the published research supporting the FDA approvals of secondary hormonal agents for nonmetastatic prostate cancer, including for patients who experience biochemical recurrence after local therapy, and apply this information in the discussion of nonresearch treatment options.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate available data with novel AKT inhibitors in combination with hormonal therapy for patients with metastatic hormone-sensitive prostate cancer and PTEN deficiency.
• Assess the available research database with PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with metastatic prostate cancer, and consider the current and potential clinical role of these strategies.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Interview: Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/PostESMO25/Micro/Prostate/1/Video and evaluation ResearchToPractice.com/PostESMO25/Micro/Prostate/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rana R McKay, MD
Professor of Medicine and Urology
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: Artera, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Natera Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Carles Galceran J et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Fizazi K et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. ESMO 2025;Abstract 2383O.

Nguyen PL et al. Randomised phase III trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303). ESMO 2025;Abstract LBA86.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of prostate cancer.

LEARNING OBJECTIVES

• Evaluate the published research supporting the FDA approvals of secondary hormonal agents for nonmetastatic prostate cancer, including for patients who experience biochemical recurrence after local therapy, and apply this information in the discussion of nonresearch treatment options.
• Assess the available research database with PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/PostESMO25/Micro/Prostate/2/Video and evaluation ResearchToPractice.com/PostESMO25/Micro/Prostate/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rana R McKay, MD, FASCO
Professor of Medicine, Urology, and Radiation Medicine and Applied Sciences
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: Artera, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Natera Inc.

Release date: February 2026
Expiration date: February 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Galceran JC et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer and prostate cancer.

LEARNING OBJECTIVES

• Evaluate the published research supporting the FDA approvals of secondary hormonal agents for nonmetastatic prostate cancer, including for patients who experience biochemical recurrence after local therapy, and apply this information in the discussion of nonresearch treatment options.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate available data with novel AKT inhibitors in combination with hormonal therapy for patients with metastatic hormone-sensitive prostate cancer and PTEN deficiency.
• Assess the available research database with PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with metastatic prostate cancer, and consider the current and potential clinical role of these strategies.
• Understand the biological rationale for combining anti-PD-1/PD-L1 antibodies with bacillus Calmette-Guerin for patients with non-muscle-invasive bladder cancer, and discuss available data with and the potential role of this novel approach.
• Analyze the scientific justification for the use of perioperative immune checkpoint inhibitor-based therapy for patients with muscle-invasive bladder cancer, and evaluate available data documenting the efficacy and safety of this therapeutic strategy.
• Reflect on pivotal clinical trial findings with novel compounds with unique mechanisms of action, such as antibody-drug conjugates, for metastatic urothelial bladder cancer (UBC), and identify patients for whom treatment with these approaches would be appropriate.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer and UBC, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/PostESMO25/Bladder/Prostate/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Terence Friedlander, MD
Professor of Medicine and Robert and Virginia O’Reilly Family Endowed Chair
Chief, Division of Hematology/Oncology
Zuckerberg San Francisco General Hospital
Helen Diller Family Comprehensive Cancer Center
University of California, San Francisco
San Francisco, California

Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

Rana R McKay, MD
Professor of Medicine and Urology
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: Artera, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP and Natera Inc.

Release date: December 2025
Expiration date: December 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Carles Galceran J et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Cho KS et al. Lymphovascular invasion of transurethral resection specimens as predictor as progression and metastasis in patients with newly diagnosed T1 bladder urothelial cancer. J Urol 2009;182(6):2625-30. Abstract

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Fizazi K et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. ESMO 2025;Abstract 2383O.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2025;[Online ahead of print]. Abstract

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Nguyen PL et al. Randomised phase III trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303). ESMO 2025;Abstract LBA86.

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Powles TB et al. A randomised phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematology-oncology fellows, urologists and other healthcare providers involved in the treatment of prostate cancer.

LEARNING OBJECTIVES

• Infer how various clinical and biological factors affect the risk of prostate cancer recurrence after local therapy, and design appropriate treatment plans for patients with consideration of the potential benefits and risks of new and established forms of hormonal therapy.
• Evaluate the published research supporting the FDA approvals of secondary hormonal agents for nonmetastatic prostate cancer, including for patients with biochemical recurrence after local therapy, and apply this information in the discussion of nonresearch treatment options.
• Explore available data with treatment intensification with cytotoxic therapy, secondary hormonal therapy or combinations of these approaches for metastatic hormone-sensitive prostate cancer, and effectively integrate these strategies into clinical management algorithms.
• Establish an evidence-based approach to the selection and sequencing of available therapeutic options for patients with metastatic castration-resistant prostate cancer (mCRPC), considering age, comorbidities, prior therapeutic exposure and other clinical and biological factors.
• Assess the available research database supporting the use of PARP inhibitors as monotherapy or in combination with androgen receptor pathway inhibitors for patients with mCRPC harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into clinical management algorithms.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for patients with mCRPC, and consider the current and potential clinical role of these strategies.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, and appropriately counsel patients about availability and participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCO2025/Prostate/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Neeraj Agarwal, MD, FASCO
Professor of Medicine
Senior Director for Clinical Research
Huntsman Cancer Institute Presidential Endowed Chair of Cancer Research
Director, Center of Investigational Therapeutics
Director, Genitourinary Oncology Program
Huntsman Cancer Institute, University of Utah (NCI-CCC)
Salt Lake City, Utah

No relevant financial relationships to disclose.

Andrew J Armstrong, MD, ScM
Professor of Medicine, Surgery, Pharmacology and Cancer Biology
Director of Research
Duke Cancer Institute Center for Prostate and Urologic Cancers
Divisions of Medical Oncology and Urology
Duke University
Durham, North Carolina

Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Cytogen Corporation, Janssen Biotech Inc, Merck, Myovant Sciences, Novartis, Pfizer Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Curium, Janssen Biotech Inc, Merck, Novartis, Pfizer Inc; Contracted Research: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Janssen Biotech Inc, Merck, Novartis, Pathos, Pfizer Inc.

Himisha Beltran, MD
Associate Professor of Medicine
Lank Center for Genitourinary Oncology and the Division of Molecular and Cellular Oncology
Director of Translational Research, Medical Oncology
Dana-Farber Cancer Institute
Boston, Massachusetts

Advisory Committees: Amgen Inc, Astellas, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Merck, Novartis, Pfizer Inc; Contracted Research: Bristol Myers Squibb, Circle Pharma, Daiichi Sankyo Inc, Novartis; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP.

Fred Saad, MD
Professor and Chairman, Department of Surgery
Raymond Garneau Chair in Prostate Cancer
University of Montreal
Director of GU Oncology
University of Montreal Hospital Center (CHUM)
Montréal, Québec, Canada

Advisory Committees and Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, GSK, Janssen Biotech Inc, Merck, Novartis, Pfizer Inc, Tolmar; Contracted Research: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, GSK, Janssen Biotech Inc, Merck, Novartis, Pfizer Inc; Speakers Bureaus: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, Merck, Novartis, Pfizer Inc, Tolmar.

MODERATOR
Rana R McKay, MD
Professor of Medicine and Urology
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: Artera, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Astellas and Pfizer Inc, Bayer HealthCare Pharmaceuticals, and Johnson & Johnson.

Release date: June 2025
Expiration date: June 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Saad

Aggarwal R et al. PRESTO: A phase III, open-label study of intensification of androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer (AFT-19). J Clin Oncol 2024;42(10):1114-23. Abstract

Attard G et al. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: A meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet 2022;399(10323):447-60. Abstract

Crook JM et al. Intermittent androgen suppression for rising PSA level after radiotherapy. N Engl J Med 2012;367(10):895-903. Abstract

Freedland SJ et al. Effects of enzalutamide on the sexual activity of patients with biochemically recurrent prostate cancer: A post hoc analysis of patient-reported outcomes in the EMBARK study. Eur Urol 2025;87(5):507-11. Abstract

Freedland SJ et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med 2023;389(16):1453-65. Abstract

Kibel AS et al. PROTEUS: A randomized, double-blind, placebo (PBO)-controlled, phase 3 trial of apalutamide (APA) plus androgen deprivation therapy (ADT) versus PBO plus ADT prior to radical prostatectomy (RP) in patients (pts) with localized or locally advanced high-risk prostate cancer (PC). Genitourinary Cancers Symposium 2022;Abstract TPS285.

Niazi T et al. DASL-HiCaP: A randomized, phase 3, double-blind trial of darolutamide with androgen-deprivation therapy and definitive or salvage radiation for localized very high-risk prostate cancer. Genitourinary Cancers Symposium 2023;Abstract TPS396.

Sandler HM et al. Patient (pt) population and radiation therapy (RT) type in the long-term phase 3 double-blind, placebo (PBO)-controlled ATLAS study of apalutamide (APA) added to androgen deprivation therapy (ADT) in high-risk localized or locally advanced prostate cancer (HRLPC). ASCO 2022;Abstract 5084.

Williams S et al. Randomised phase 3 trial of enzalutamide in androgen deprivation therapy (ADT) with radiation therapy for high risk, clinically localized prostate cancer: ENZARAD (ANZUP 1303). Genitourinary Cancers Symposium 2018;Abstract TPS156.

 

Dr Armstrong

Armstrong AJ et al. ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). ASCO 2025;Abstract 5005.

Armstrong AJ et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol 2022;40(15):1616-22. Abstract

Azad AA et al. Combination therapies in locally advanced and metastatic hormone-sensitive prostate cancer. Eur Urol 2025;87(4):455-67. Abstract

Azad AA et al. Enzalutamide and prostate-specific antigen levels in metastatic prostate cancer. JAMA Netw Open 2025;8(5). Abstract

Chi KN et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: Final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol 2021;39(20):2294-303. Abstract

Chowdhury S et al. Deep, rapid, and durable prostate-specific antigen decline with apalutamide plus androgen deprivation therapy is associated with longer survival and improved clinical outcomes in TITAN patients with metastatic castration-sensitive prostate cancer. Ann Oncol 2023;34(5):477-85. Abstract

Fisher DJ et al. Which patients with metastatic hormone-sensitive prostate cancer (mHSPC) benefit more from androgen receptor pathway inhibitors (ARPIs)? STOPCAP meta-analyses of individual participant data (IPD). Genitourinary Cancers Symposium 2025;Abstract 20.

Fizazi K et al. Health-related quality of life and pain outcomes with [¹⁷⁷Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): A multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2023;24(6):597-610. Abstract

Hussain M et al. Darolutamide plus androgen-deprivation therapy and docetaxel in metastatic hormone-sensitive prostate cancer by disease volume and risk subgroups in the phase III ARASENS trial. J Clin Oncol 2023;41(20):3595-607. Abstract

McManus HD, Armstrong AJ. The past, present, and future of treatment intensification for metastatic hormone-sensitive prostate cancer. J Clin Oncol 2023;41(20):3576-9. Abstract

Merseburger AS et al. Targeted investigational treatment analysis of novel anti-androgen (TITAN) study: Ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy. BJU Int 2024;134(6):982-91. Abstract

Saad F et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol 2024;42(36):4271-81. Abstract

Saad F et al. Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial. ESMO 2024;Abstract LBA68.

 

Dr Agarwal

Agarwal N et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA18.

Agarwal N et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): A randomised, placebo-controlled, phase 3 trial. Lancet 2023;402(10398):291-303. Abstract

Chi KN et al. Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol 2023;41(18):3339-51. Abstract

Chi KN et al. Phase 3 MAGNITUDE study: First results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. Genitourinary Cancers Symposium 2022;Abstract 12.

Clarke NW et al. Final overall survival (OS) in PROpel: Abiraterone (abi) and olaparib (ola) versus abiraterone and placebo (pbo) as first-line (1L) therapy for metastatic castration-resistant prostate cancer (mCRPC). Genitourinary Cancers Symposium 2023;Abstract LBA16.

Clarke NW et al. Abiraterone and olaparib for metastatic castration-resistant prostate cancer. NEJM Evid 2022;1(9). Abstract

Hussain MHA et al. BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm). Genitourinary Cancers Symposium 2024;Abstract 19.

Saad F et al. PROpel: Phase III trial of olaparib (ola) and abiraterone (abi) versus placebo (pbo) and abi as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Genitourinary Cancers Symposium 2022;Abstract 11.

 

Dr McKay

Azad AA et al. UpFrontPSMA: A randomised phase II study of sequential 177Lu-PSMA-617 and docetaxel (D) versus docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). ESMO 2024;Abstract LBA66.

Emmett L et al. Overall survival and quality of life with [¹⁷⁷Lu] Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in poor-risk, metastatic, castration-resistant prostate cancer in ENZA-p (ANZUP 1901). Genitourinary Cancers Symposium 2025;Abstract 17.

Gillessen S et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. ESMO 2024;Abstract LBA1.

Higano CS et al. Clinical outcomes and treatment patterns in REASSURE: Planned interim analysis of a real-world observational study of radium-223 in metastatic castration-resistant prostate cancer. EClinicalMedicine 2023;60:101993. Abstract

Morris MJ et al. ¹⁷⁷Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomised, controlled trial. Lancet 2024;404(10459):1227-39. Abstract

Parker C et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3):213-23. Abstract

Raval AD et al. Real-world utilization patterns and survival in men with metastatic prostate cancer treated with Radium-223 in the United States. Prostate Cancer Prostatic Dis 2025;[Online ahead of print]. Abstract

Sartor O et al. Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH). ESMO 2024;Abstract LBA65.

Sartor O et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med 2021;385(12):1091-103. Abstract

 

Dr Beltran

Beltran H et al. Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer. Nat Med 2016;22(3):298-305. Abstract

de Bono JS et al. Exploratory gene-by-gene analysis of olaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): PROfound. Genitourinary Cancers Symposium 2021;Abstract 126.

DeWeese TL et al. Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer. ASCO 2025;Abstract 5000.

Schweizer MT et al. Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Genitourinary Cancers Symposium 2025;Abstract LBA138.

Sweeney C et al. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): A multicentre, randomised, double-blind, phase 3 trial. Lancet 2021;398(10295):131-42. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of renal cell carcinoma.

LEARNING OBJECTIVES

• Evaluate recently presented data with adjuvant anti-PD-1/PD-L1 antibody therapy for patients with RCC at high risk for recurrence after nephrectomy, and consider the current role of this treatment strategy.
• Appraise available clinical trial data evaluating anti-PD-1/PD-L1 antibody/multikinase inhibitor combinations for previously untreated metastatic RCC (mRCC), and counsel patients regarding the risks and benefits of these novel regimens.
• Review the biological rationale underlying the investigation of anti-PD-1/anti-CTLA-4 combination therapy as first-line treatment for patients with mRCC, and appreciate long-term research findings documenting the effectiveness of this approach.
• Assess recently presented clinical trial results with anti-PD-1/PD-L1 antibodies administered as a subcutaneous injection for patients with mRCC, and reflect on the potential benefits of this therapeutic strategy.
• Understand the biological rationale for exploiting HIF-2α in patients with von Hippel-Lindau-associated and sporadic RCC, and consider the current role of available inhibitors.
• Develop a rational therapeutic approach to the sequencing of systemic therapies for patients with advanced RCC that progresses on first-line treatment, incorporating multikinase inhibitors, HIF-2α inhibitors, immunotherapeutic agents and other strategies.
• Appreciate published research findings evaluating the use of available and investigational agents for patients with non-clear cell RCC, and consider the applicability of these strategies in clinical care.
• Recall available and emerging data with other novel and investigational agents and strategies in testing for RCC, and as applicable, refer eligible patients for clinical trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
CME credit is no longer available for this issue

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a short post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of an video component.
CME credit is no longer available for this issue

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Thomas E Hutson, DO, PharmD, PhD
Director
UMC Cancer Center
Division Chief, Hematology and Medical Oncology
Professor of Medicine
CH Endowed Chair
Texas Tech University Health Sciences Center School of Medicine
Lubbock, Texas

Advisory Committees, Consulting Agreements, Contracted Research and Speakers Bureaus: Astellas, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Exelixis Inc, Merck, Pfizer Inc, Seagen Inc.

Rana R McKay, MD
Professor of Medicine and Urology
Associate Director, Clinical Research
Co-Lead, Genitourinary Program
Moores Cancer Center
University of California San Diego
San Diego, California

Advisor/Consultant: Ambrx, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Exelixis Inc, Johnson & Johnson Pharmaceuticals, Lilly, Merck, Myovant Sciences, Neomorph, Novartis, Pfizer Inc, Sanofi, Seagen Inc, Sorrento Therapeutics, Telix Pharmaceuticals Limited, Tempus; Institutional Research Funding: ArteraAI, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Exelixis Inc, Oncternal Therapeutics, Tempus.

Tian Zhang, MD, MHS
Associate Professor
Director of Clinical Research
Division of Hematology and Oncology
Department of Internal Medicine
UT Southwestern Medical Center
Associate Director for Clinical Research
Simmons Comprehensive Cancer Center
Dallas, Texas

Advisory Committees: Amgen Inc, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merck, Novartis, Pfizer Inc, Sanofi; Consulting Agreements: Aptitude Health, DAVA Oncology, Pfizer Inc, Vaniam Group; Contracted Research: ALX Oncology, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Exelixis Inc, Janssen Biotech Inc, Janux Therapeutics, Lilly, Merck, OncoC4, Pfizer Inc, Tempus; Nonrelevant Financial Relationships: Mashup Media LLC, MJH Life Sciences, PeerView.

MODERATOR
Sumanta Kumar Pal, MD
Professor and Vice Chair of Academic Affairs
Department of Medical Oncology
City of Hope Comprehensive Cancer Center
Duarte, California

Travel Support: CRISPR Therapeutics, EverImmune, Exelixis Inc, Ipsen Biopharmaceuticals Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Bristol Myers Squibb, Eisai Inc, and Exelixis Inc.

Release date: March 2025
Expiration date: March 2026

Dr Hutson

Albiges L et al. Cabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in previously untreated advanced renal cell carcinoma (aRCC): Final results of COSMIC-313. Genitourinary Cancers Symposium 2025;Abstract 438.

Bourlon MT et al. Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). Genitourinary Cancers Symposium 2024;Abstract 362.

Choueiri TK et al. Overall survival results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab versus placebo for the treatment of clear cell renal cell carcinoma (ccRCC). ASCO 2024;Abstract LBA359.

Choueiri TK et al. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. N Engl J Med 2024;390(15):1359-71. Abstract

George S et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. Genitourinary Cancers Symposium 2024;Abstract LBA360.

Grünwald V et al. Analyses on impact of tumor burden at progression and changes in IMDC from baseline in patients (pts) with advanced renal cell carcinoma (aRCC) treated with lenvatinib + pembrolizumab (L+P) in the phase 3 CLEAR trial. Genitourinary Cancers Symposium 2025;Abstract 531.

Motzer RJ et al. Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Final follow-up results from the CheckMate 9ER trial. Genitourinary Cancers Symposium 2025;Abstract 439.

Motzer RJ et al. Lenvatinib plus pembrolizumab versus sunitinib in first-line treatment of advanced renal cell carcinoma: Final prespecified overall survival analysis of CLEAR, a phase III study. J Clin Oncol 2024;42(11):1222-8. Abstract

Motzer RJ et al. Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). ASCO 2023;Abstract 4502.

Powles T et al. Outcomes by IMDC risk in the COSMIC-313 phase 3 trial evaluating cabozantinib (C) plus nivolumab (N) and ipilimumab (I) in first-line advanced RCC (aRCC) of IMDC intermediate or poor risk. Genitourinary Cancers Symposium 2023;Abstract 605.

Rini BI et al. Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma: 5-year analysis of KEYNOTE-426. ASCO 2023;Abstract LBA4501.

Tannir NM et al. Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): Long-term follow-up data from the phase 3 CheckMate 214 trial. Genitourinary Cancers Symposium 2024;Abstract 363.

 

Dr Zhang

Braun DA et al. Beyond conventional immune-checkpoint inhibition — Novel immunotherapies for renal cell carcinoma. Nat Rev Clin Oncol 2021;18(4):199-214. Abstract

Choueiri TK et al. Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): Results of the phase III TiNivo-2 study. ESMO 2024;Abstract LBA73.

Pal SK et al. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): A multicentre, randomised, open-label, phase 3 trial. Lancet 2023;402(10397):185-95. Abstract

Rini BI et al. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): A phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol 2020;21(1):95-104. Abstract

Zhu S et al. Combination strategies to maximize the benefits of cancer immunotherapy. J Hematol Oncol 2021;14(1):156. Abstract

 

Dr McKay

Agarwal N et al. Randomized phase II dose comparison LITESPARK-013 study of belzutifan in patients with advanced clear cell renal cell carcinoma. Ann Oncol 2024;35(12):1148-56. Abstract

Albiges L et al. KEYMAKER-U03 Substudy 03B: Pembrolizumab (pembro) and targeted therapy combinations for advanced clear cell renal cell carcinoma (ccRCC). Genitourinary Cancers Symposium 2025;Abstract 440.

Barata P et al. Renal cell carcinoma histologic subtypes exhibit distinct transcriptional profiles. J Clin Invest 2024;134(11):e178915. Abstract

Choueiri TK et al. Belzutifan plus cabozantinib as first-line treatment for patients with advanced clear-cell renal cell carcinoma (LITESPARK-003): An open-label, single-arm, phase 2 study. Lancet Oncol 2025;26(1):64-73. Abstract

Choueiri TK et al. Casdatifan (Cas) monotherapy in patients (pts) with previously treated clear cell renal cell carcinoma (ccRCC): Safety, efficacy and subgroup analysis across multiple doses from ARC-20, a phase 1 open-label study. Genitourinary Cancers Symposium 2025;Abstract 441.

Choueiri TK et al. Updated results from the phase 2 LITESPARK-003 study of belzutifan plus cabozantinib in patients with advanced clear cell renal cell carcinoma (ccRCC). Genitourinary Cancers Symposium 2025;Abstract 549.

Choueiri TK et al. Casdatifan in patients (pts) with previously treated clear cell renal cell cancer (ccRCC) and other solid tumors; preliminary results from ARC- 20: A phase 1, open-label dose-escalation and expansion study. EOORTC-NCI-AACR Symposium 2024;Abstract 4 Oral.

Choueiri TK et al. Safety profile of belzutifan monotherapy in patients with renal cell carcinoma: A pooled analysis of 4 clinical trials. KCRS 2024;Abstract 39.

Choueiri TK et al. LITESPARK-012: Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. Future Oncol 2023;19(40):2631-40. Abstract

Choueiri TK et al. Phase 3 LITESPARK-022: Pembrolizumab (pembro) plus hypoxia-inducible factor 2α (HIF-2α) inhibitor belzutifan as adjuvant treatment for clear cell renal cell carcinoma (ccRCC). Genitourinary Cancers Symposium 2023;Abstract TPS748.

Choueiri TK et al. Phase II LITESPARK-003 study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC). ESMO 2023;Abstract LBA87.

de Velasco G et al. Efficacy outcomes with belzutifan versus everolimus by baseline disease characteristics and burden subgroups in the phase 3 LITESPARK-005 study. Genitourinary Cancers Symposium 2025;Abstract 538.

Jonasch E et al. NKT2152, a novel oral HIF-2α inhibitor, in participants (pts) with previously treated advanced clear cell renal carcinoma (accRCC): Preliminary results of a phase I/II study. ESMO 2024;Abstract 16900.

Jonasch E et al. Belzutifan for renal cell carcinoma in von Hippel-Lindau disease. N Engl J Med 2021;385(22):2036-46. Abstract

Motzer RJ et al. LITESPARK-011: Belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. Future Oncol 2023;19(2):113-21. Abstract

Pezzicoli G et al. Genomic profiling and molecular characterization of clear cell renal cell carcinoma. Curr Oncol 2023;30(10):9276-90. Abstract

Rini BI et al. Final analysis of the phase III LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC). ESMO 2024;Abstract LBA74.

 

Dr Pal

Albiges L et al. Pembrolizumab plus lenvatinib as first-line therapy for advanced non-clear-cell renal cell carcinoma (KEYNOTE-B61): A single-arm, multicentre, phase 2 trial. Lancet Oncol 2023;24(8):881-91. Abstract

Alhalabi O et al. Immune checkpoint therapy combinations in adult advanced MiT family translocation renal cell carcinomas. Oncologist 2023;28(5):433-9. Abstract

Bakouny Z et al. Integrative clinical and molecular characterization of translocation renal cell carcinoma. Cell Rep 2022;38(1):110190. Abstract

Barata P et al. Final overall survival analysis of S1500: A randomized, phase II study comparing sunitinib with cabozantinib, crizotinib, and savolitinib in advanced papillary renal cell carcinoma. J Clin Oncol 2024;42(33):3911-6. Abstract

Fitzgerald KN et al. Cabozantinib plus nivolumab in patients with non-clear cell renal cell carcinoma: Updated results from a phase 2 trial. Eur Urol 2024;86(2):90-4. Abstract

Hutson TE et al. A single-arm, multicenter, phase 2 study of lenvatinib plus everolimus in patients with advanced non-clear cell renal cell carcinoma. Eur Urol 2021;80(2):162-70. Abstract

McGregor BA et al. Results of a multicenter phase II study of atezolizumab and bevacizumab for patients with metastatic renal cell carcinoma with variant histology and/or sarcomatoid features. J Clin Oncol 2020;38(1):63-70. Abstract

Montenegro GLB et al. A phase 2 study of bevacizumab, erlotinib, and atezolizumab in subjects with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC) associated or sporadic papillary renal cell cancer (pRCC). ASCO 2022;Abstract 5004.

Naik P et al. The incidence, pathogenesis, and management of non-clear cell renal cell carcinoma. Ther Adv Urol 2024:16. Abstract

Pal SK et al. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: A randomised, open-label, phase 2 trial. Lancet 2021;397(10275):695-703. Abstract

Pal SK et al. Cabozantinib in combination with atezolizumab for advanced renal cell carcinoma: Results from the COSMIC-021 study. J Clin Oncol 2021;39(33):3725-36. Abstract

Procopio G et al. Cabozantinib as first-line treatment in patients with metastatic collecting duct renal cell carcinoma: Results of the BONSAI trial for the Italian Network for Research in Urologic-Oncology (Meet-URO 2 Study). JAMA Oncol 2022;8(6):910-3. Abstract

Salgia NJ et al. Renal cell carcinoma of variant histology: New biologic understanding leads to therapeutic advances. Am Soc Clin Oncol Educ Book 2024;44(3):e438642. Abstract

Sharma MR et al. A phase I first-in-human study of XL092 in patients (pts) with locally advanced or metastatic solid tumors: Results from dose-escalation of XL092 alone and in combination with atezolizumab. ESMO 2022;Abstract 481P.

Suarez C et al. Phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). J Clin Oncol 2023;41(14):2493-502. Abstract

Voss MH et al. First-line pembrolizumab plus lenvatinib for non–clear cell renal carcinomas (nccRCC): Extended follow-up of the phase 2 KEYNOTE-B61 study. Genitourinary Cancers Symposium 2024;Abstract 2.

Wiele AJ et al. Efficacy and safety of bevacizumab plus erlotinib in patients with renal medullary carcinoma. Cancers (Basel) 2021;13(9):2170. Abstract

Wilson NR et al. Efficacy and safety of gemcitabine plus doxorubicin in patients with renal medullary carcinoma. Clin Genitourin Cancer 2021;19(6):e401-8. Abstract