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 bladder and prostate cancers.

LEARNING OBJECTIVES

• Recognize the incidence of nectin-4 expression in urothelial bladder cancer (UBC), and appreciate the scientific justification for the development of antibody-drug conjugates (ADCs) targeting this novel biomarker.
• Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with ADC therapy as first-line treatment for metastatic UBC, and consider the current role of this strategy.
• Review available research findings with HER2-directed ADCs for patients with advanced UBC, and optimally integrate these novel agents into management algorithms.
• Appraise published research on the optimal management of biochemical recurrence after local treatment for prostate cancer, and counsel appropriate patients about the potential benefits of FDA-approved systemic 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.
• Assess the available research database supporting the use of PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic castration-resistant prostate cancer harboring a homologous recombination repair gene alteration, and discern the current role of this treatment approach.
• Recall the design of ongoing clinical trials evaluating novel ADCs for advanced UBC or hormonal therapy-based approaches for prostate cancer, and counsel appropriate patients about availability and 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
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)
CME credit is no longer available for this issue

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
CME credit is no longer available for this issue

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.
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:

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 conflicts of interest 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.

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, Pfizer Inc; Contracted Research: Bicycle Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson Pharmaceuticals, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Bicycle Therapeutics.

Matthew D Galsky, MD
Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Advisory Committees: AbbVie Inc, Aktis Oncology, Alligator Bioscience, Analog Devices Inc, Asieris Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Basilea Pharmaceutica Ltd, Bicycle Therapeutics, Bristol Myers Squibb, Curis Inc, Daiichi Sankyo Inc, Dragonfly Therapeutics, EMD Serono Inc, FUJIFILM Pharmaceuticals USA Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Janssen Biotech Inc, Merck, Numab Therapeutics AG, Pfizer Inc, Rappta Therapeutics, Seagen Inc, Silverback Therapeutics, UroGen Pharma, Veracyte Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Dendreon Pharmaceuticals Inc, Genentech, a member of the Roche Group, Merck, Novartis.

MODERATOR
Elisabeth I Heath, MD
Chair, Department of Oncology
Mayo Clinic
Rochester, Minnesota

Advisory/Consulting: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Sanofi; Honoraria/Paid Travel: Astellas, Bayer HealthCare Pharmaceuticals, Caris Life Sciences, Sanofi, Seagen Inc; Institutional Research Support: Amgen Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BioXcel Therapeutics Inc, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Corcept Therapeutics, Corvus Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exelixis Inc, F Hoffman-La Roche Ltd, Fortis Therapeutics, Gilead Sciences Inc, GSK, Harpoon Therapeutics, Infinity Pharmaceuticals Inc, iTeos Therapeutics, Janssen Biotech Inc, Merck, Mirati Therapeutics Inc, Modra Pharmaceuticals, MSD, Novartis, Oncolys BioPharma, Peloton Therapeutics Inc, a wholly-owned subsidiary of Merck & Co Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, POINT Biopharma, Seagen Inc; Steering Committees: Janssen Biotech Inc; Speakers Bureaus: Sanofi; Nonrelevant Financial Relationships: Calibr-Skaggs Institute for Innovative Medicines.

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 grantor.

These activities are supported by an educational grant from Astellas and Pfizer Inc.

Release date: March 2025
Expiration date: March 2026

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

Urothelial Bladder Cancer

Dr Friedlander

O’Donnell PH et al. Enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer. J Clin Oncol. 2023 Sep 1;41(25):4107-17. Abstract

Powles T et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Genitourinary Cancers Symposium 2025;Abstract 664.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Powles T et al. EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). ESMO 2023;Abstract LBA6.

Powles T et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med 2021;384(12):1125-35. Abstract

Rosenberg JE et al. Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. ASCO 2022;Abstract 4516.

Rosenberg JE et al. Study EV-103 cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC). ESMO 2022;Abstract LBA73.

 

Dr Galsky

Aggen DH et al. HER2 and PD-L1 immunohistochemistry (IHC) expression, and HER2 genomic alterations: Associations and clinical outcomes for advanced bladder cancer. Genitourinary Cancers Symposium 2024;Abstract 538.

Galsky MD et al. Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 cohort C. ESMO 2024;Abstract 1967MO.

Galsky MD et al. Phase 2 multi-cohort clinical study evaluating disitamab vedotin alone and in combination with pembrolizumab in patients with HER2-expressing unresectable or metastatic urothelial carcinoma (RC48G001, trial in progress). SITC 2022;Abstract 663.

Galsky MD et al. Primary analysis from DS8201-A-U105: A phase 1b, 2-part, open-label study of trastuzumab deruxtecan (T-DXd) with nivolumab (nivo) in patients (pts) with HER2-expressing urothelial carcinoma (UC). Genitourinary Cancers Symposium 2022;Abstract 438.

Grivas P et al. Sacituzumab govitecan in combination with pembrolizumab for patients with metastatic urothelial cancer that progressed after platinum-based chemotherapy: TROPHY-U-01 cohort 3. J Clin Oncol 2024;42(12):1415-25. Abstract

Hamilton E et al. Trastuzumab deruxtecan with nivolumab in HER2-expressing metastatic breast or urothelial cancer: Analysis of the phase Ib DS8201-A-U105 study. Clin Cancer Res. 2024;30(24):5548-58. Abstract

Li BT et al. Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): An international, phase 2 study. Lancet Oncol 2024;25(6):707-19. Abstract

Li BT et al. Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with solid tumors harboring specific HER2-activating mutations (HER2m): Primary results from the international phase II DESTINY-PanTumor01 (DPT-01) study. ESMO 2023;Abstract 654O.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Meric-Bernstam F et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study. ESMO 2023;Abstract LBA34.

O’Donnell PH et al. Enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer. J Clin Oncol 2023;41(25):4107-17. Abstract

Rosenberg JE et al. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. Ann Oncol 2023;34(11):1047-54. Abstract

Sheng X et al. Efficacy and safety of disitamab vedotin in patients with human epidermal growth factor receptor 2-positive locally advanced or metastatic urothelial carcinoma: A Combined analysis of two phase II clinical trials. J Clin Oncol 2024;42(12):1391-402. Abstract

Sheng X et al. RC48-ADC for metastatic urothelial carcinoma with HER2-positive: Combined analysis of RC48-C005 and RC48-C009 trials. ASCO 2022;Abstract 4520.

Xu H et al. A phase II study of RC48-ADC in HER2-negative patients with locally advanced or metastatic urothelial carcinoma. ASCO 2022;Abstract 4519.

Zhou L et al. Disitamab vedotin (DV) plus toripalimab (T) in unresectable locally advanced or metastatic urothelial carcinoma (la/mUC): Long-term outcomes from a phase Ib/II study. ESMO 2024;Abstract 1979P.

 

Prostate Cancer

Dr Armstrong

Armstrong AJ et al. The efficacy of enzalutamide plus androgen deprivation therapy in oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES. Eur Urol 2023;84(2):229-41. Abstract

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

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

Attard G et al. Comparison of abiraterone acetate and prednisolone (AAP) or combination enzalutamide (ENZ) + AAP for metastatic hormone sensitive prostate cancer (mHSPC) starting androgen deprivation therapy (ADT): Overall survival (OS) results of 2 randomised phase III trials from the STAMPEDE protocol. ESMO 2022;Abstract LBA62.

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

Smith MR et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med 2022;386(12):1132-42. Abstract

Smith MR et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. Genitourinary Cancers Symposium 2022;Abstract 13.

Sweeney CJ et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med 2015;373(8):737-46. Abstract

Tang C et al. Addition of metastasis-directed therapy to intermittent hormone therapy for oligometastatic prostate cancer: The EXTEND phase 2 randomized clinical trial. JAMA Oncol 2023;9(6):825-34. Abstract

 

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. EvoPAR-Prostate01: Phase III, double-blind, placebo-controlled, 2-cohort, randomized study of saruparib (AZD5305) in combination with new hormonal agents in patients with mCSPC +/- HRR mutations. AUA 2024.

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

Agarwal N et al. Talapro-3: A phase 3, double-blind, randomized study of enzalutamide (ENZA) plus talazoparib (TALA) versus placebo plus enza in patients with DDR gene mutated metastatic castration-sensitive prostate cancer (mCSPC). Genitourinary Cancers Symposium 2022;Abstract TPS 221.

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. Niraparib (NIRA) with abiraterone acetate plus prednisone (AAP) as first-line (1L) therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: Three-year update and final analysis (FA) of MAGNITUDE. ESMO 2023;Abstract LBA85.

Chi KN et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: Second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol 2023;34(9):772-82. 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. Abiraterone and olaparib for metastatic castration-resistant prostate cancer. NEJM Evid 2022;1(9). Abstract

Fizazi K et al. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: The phase 3 TALAPRO-2 trial. Nat Med 2024;30(1):257-64. Abstract

Hussain M 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.

Rathkopf DE et al. AMPLITUDE: A study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). Genitourinary Cancers Symposium 2021;Abstract TPS176.

Saad F et al. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): Final prespecified overall survival results of a randomised, double-blind, phase 3 trial. Lancet Oncol 2023;24(10):1094-108. Abstract

Swami U et al. Treatment pattern and outcomes with systemic therapy in men with metastatic prostate cancer in the real-world patients in the United States. Cancers (Basel) 2021;13(19):4951. Abstract