Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Prostate Cancer — Faculty Presentation: Professor Karim Fizazi, MD, PhD

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals 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 individual treatment plans for patients with consideration of the potential benefits and risks of new and established forms of hormonal therapy.
• Appraise published research findings on optimal management approaches for patients with biochemical recurrence after local treatment for prostate cancer, and offer appropriate counseling about the potential benefits of FDA-approved systemic treatment options.
• Evaluate the published research database supporting the FDA approvals of secondary hormonal agents in the management of nonmetastatic prostate cancer, and apply this information in the discussion of nonresearch treatment options with patients.
• Explore available data with treatment intensification with cytotoxic therapy, secondary hormonal therapy or combinations of these approaches for metastatic hormone-sensitive prostate cancer (mHSPC), and effectively integrate these strategies into clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway in prostate cancer, and evaluate emerging data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and a PTEN deficiency.
• 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 counsel appropriate 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 1.75 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 this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.75 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 the 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 this CME activity, 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.

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HOW TO USE THIS CME ACTIVITY
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/YiR2024/Prostate/Presentations/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:

Emmanuel S Antonarakis, MD
Clark Endowed Professor of Medicine
Division of Hematology, Oncology and Transplantation
University of Minnesota
Minneapolis, Minnesota

Advisory Committees: Abeona Therapeutics Inc, AstraZeneca Pharmaceuticals LP, Blue Earth Diagnostics, Boundless Bio, Curium, Forbion, Sanofi, Tango Therapeutics; Consulting Agreements: Acerand Therapeutics, Clarity Pharmaceuticals, Curium, EcoR1 Capital LLC, Health Monitor, Lilly, LinKinVax, Vir Biotechnology Inc, Z-Alpha; Contracted Research: Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, MacroGenics Inc, Novartis, Orion Corporation, pharmaand GmbH, Seagen Inc.

Professor Karim Fizazi, MD, PhD
Head of Service and Full Professor
Institut Gustave Roussy
University of Paris Saclay
Villejuif, France

Institutional Honoraria: Advanced Accelerator Applications, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Janssen Biotech Inc, Merck, MSD, Novartis, Pfizer Inc.

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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, 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, 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, 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 Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Merck.

Release date: May 2025
Expiration date: May 2026

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

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. Cabozantinib (C) plus atezolizumab (A) versus 2nd novel hormonal therapy (NHT) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC): Final overall survival (OS) results of the phase III, randomized, CONTACT-02 study. ESMO 2024;Abstract LBA67.

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

André F et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract

Azad A et al. Phase III, double-blind, placebo-controlled, 2-cohort, randomized study of saruparib (AZD5305) in combination with androgen receptor pathway inhibitors in patients with metastatic hormone-sensitive prostate cancer with and without homologous recombination repair mutation (EvoPAR-Prostate01). Genitourinary Cancers Symposium 2025;Abstract TPS279.

Azad A et al. Apalutamide (APA) plus intermittent versus continuous androgen-deprivation therapy (ADT) in participants (pts) with metastatic castration-sensitive prostate cancer (mCSPC): LIBERTAS phase 3 study design. Genitourinary Cancers Symposium 2024;Abstract TPS236.

Emmett L et al. Overall survival and quality of life with [(177)Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): Secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 2025;26(3):291-9. Abstract

Fizazi K et al. MK-5684 (ODM-208), a CYP11A1 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) with and without AR-LBD mutations: CYPIDES phase 2 results. Genitourinary Cancers Symposium 2024;Abstract 159.

Fizazi K et al. Targeted inhibition of CYP11A1 in castration-resistant prostate cancer. NEJM Evid 2024;3(1). 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

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.

Gomez-Veiga F et al. Clinical outcomes of enzalutamide in metastatic hormone-sensitive prostate cancer in patients aged <75 and 75 years: ARCHES post hoc analysis. Eur Urol Oncol 2024;7(4):860-9. Abstract

Gratzke CJ et al. Phase 3 OMAHA-004 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after 1 prior NHA. Genitourinary Cancers Symposium 2025;Abstract TPS301.

Hadaschik BA et al. PRIMORDIUM: A randomized, international, trial-in-progress of adding apalutamide to radiotherapy and an LHRH agonist in high-risk patients with PSMA-PET-positive hormone-sensitive prostate cancer. ESMO 2021;Abstract 649TiP.

Hussain MH et al. Abiraterone, olaparib, or abiraterone + olaparib in first-line metastatic castration-resistant prostate cancer with DNA repair defects (BRCAAway). Clin Cancer Res 2024;30(19):4318-28. Abstract

Morgans AK et al. Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP). Genitourinary Cancers Symposium 2025;Abstract TPS432.

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

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Parker CC et al. Randomised trial of no, short-term, or long-term androgen deprivation therapy with postoperative radiotherapy after radical prostatectomy: Results from the three-way comparison of RADICALS-HD (NCT00541047). Eur Urol 2024;86(5):422-30. Abstract

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.

Roubaud G et al. Adjustment for imbalances in baseline characteristics in the MAGNITUDE phase 3 study confirms the clinical benefit of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic prostate cancer. Eur J Cancer 2024;209:114183. Abstract

Roy S et al. Early prostate-specific antigen response by 6 months is predictive of treatment effect in metastatic hormone sensitive prostate cancer: An exploratory analysis of the TITAN trial. J Urol 2024;212(5):672-81. Abstract

Saad F et al. Efficacy of olaparib (ola) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with a germline or somatic BRCA mutation in the PROpel trial. Genitourinary Cancers Symposium 2025;Abstract 219.

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. Deep and durable prostate-specific antigen response to darolutamide with androgen deprivation therapy and docetaxel, and association with clinical outcomes for patients with high- or low-volume metastatic hormone-sensitive prostate cancer: Analyses of the randomized phase 3 ARASENS study. Eur Urol 2024;86(4):329-39. 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.

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.

Shore N et al. Apalutamide for high-risk localized prostate cancer following radical prostatectomy (Apa-RP). J Urol 2024;212(5):682-91. Abstract

Shore ND et al. Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age. ESMO 2024;Abstract 1638P.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

Tutrone R et al. Testosterone recovery for relugolix versus leuprolide in men with advanced prostate cancer: Results from the phase 3 HERO study. Eur Urol Oncol 2024;7(4):906-13. Abstract

Yu EY et al. OMAHA-003: A phase 3 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in metastatic castration-resistant prostate cancer (mCRPC) after NHA and taxane-based chemotherapy. Genitourinary Cancers Symposium 2025;Abstract TPS286.