Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Prostate Cancer — Presentation: Andrew J Armstrong, MD, ScM

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, 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 individual 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 counsel appropriate individuals regarding the potential benefits of FDA-approved systemic treatment options.
• Evaluate the published research database supporting the FDA approvals of secondary hormonal agents for the management of nonmetastatic prostate cancer, and apply this information in the discussion of nonresearch treatment options.
• Explore available data with the use of 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 current 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, considering age, comorbidities, prior therapeutic exposure and other relevant clinical and biological factors.
• Assess the available research database supporting the use of 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 current clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway for prostate cancer, and evaluate available and emerging data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and PTEN deficiency.
• Review available and emerging Phase III data documenting the efficacy of various forms of radioligand therapy for patients with metastatic prostate cancer, and consider the current and potential future 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 AMA PRA Category 1 Credit™. 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 Medical Knowledge MOC point 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 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.

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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/YIR2025/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:

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
Division of Medical Oncology
Departments of Medicine and Urology
Duke University
Durham, North Carolina

Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Merck, Pfizer Inc, Precede Biosciences, Sumitomo Pharma America, Telix Pharmaceuticals Limited; Consulting Agreements: Amgen Inc, Astellas, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, Novartis, Pfizer Inc; Contracted Research: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, FibroGen Inc, Janssen Biotech Inc, Merck, Novartis, Pathos, Pfizer Inc.

Scott T Tagawa, MD, MS
Professor of Medicine and Urology
Weill Cornell Medicine
Leader, GU Disease Management Team
Meyer Cancer Center
New York, New York

Consulting Agreements: AbbVie Inc, Abdera Therapeutics, Bayer HealthCare Pharmaceuticals, Biohaven, Blue Earth Diagnostics, Boston Scientific Corporation, Clarity Pharmaceuticals, Convergent Therapeutics Inc, Daiichi Sankyo Inc, EMD Serono Inc, GE Healthcare, Gilead Sciences Inc, Johnson & Johnson, Lantheus, Lilly, Merck, Myovant Sciences, Novartis, Pfizer Inc, Regeneron Pharmaceuticals Inc, Telix Pharmaceuticals Limited; Contracted Research: AIQ Solutions, Bayer HealthCare Pharmaceuticals, Clarity Pharmaceuticals, Gilead Sciences Inc, Janux Therapeutics, Johnson & Johnson, Lilly, Merck, Novartis, Pfizer Inc, Telix Pharmaceuticals Limited; Data and Safety Monitoring Boards/Committees: Boston Scientific Corporation; Stock OPTIONS — Private Companies: Convergent Therapeutics.

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, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, 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.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Merck, Novartis, and Sumitomo Pharma America and Pfizer Inc.

Release date: April 2026
Expiration date: April 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.

Armstrong AJ et al. Trial design and objectives for patients with prostate cancer: Recommendations from the prostate cancer working group 4. J Clin Oncol 2026;[Online ahead of print]. Abstract

De Bono JS et al. IDeate-Prostate02: A phase 1/2, open-label umbrella substudy of ifinatamab deruxtecan-based treatment combinations or as monotherapy in participants with previously treated metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract TPS297.

De La Cerda J et al. Safety and tolerability of relugolix in combination with abiraterone or apalutamide for treatment of patients with advanced prostate cancer: Data from a 52-week clinical trial. Target Oncol 2025;20(3):503-17. Abstract

Emmett L et al. PSMAcTION trial-in-progress: A phase II/III randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy. ESMO 2025;Abstract 2516TiP.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2026;37(1):53-68. Abstract

Fizazi K et al. OMAHA-004: Phase 3 trial of CYP11A1 inhibitor opevesostat versus androgen receptor pathway inhibitor (ARPI) switch in participants with metastatic castration-resistant prostate cancer (mCRPC) after a prior ARPI. Genitourinary Cancers Symposium 2026;Abstract TPS299.

Fizazi K et al. Final overall survival and safety analyses of the phase III PSMAfore trial of [(177)Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer. Ann Oncol 2025;36(11):1319-30. Abstract

Francolini G et al. Ultra-hypofractionated radiotherapy and concomitant oral relugolix for treatment of intermediate risk prostate cancer (ULTRA-HERO). Genitourinary Cancers Symposium 2026;Abstract TPS411.

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

Gallardo E et al. Final overall survival results from the EORTC 1333/PEACE-3 trial: Enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract 15.

George DJ et al. Patient reported outcomes (PRO) and tolerability of capivasertib (capi) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Genitourinary Cancers Symposium 2026;Abstract 14.

Grimm M-O et al. 3-weekly docetaxel 75 mg/m² vs 2-weekly docetaxel 50 mg/m² in combination with darolutamide + ADT in patients with mHSPC: Results from the randomised phase III ARASAFE trial. ESMO 2025;Abstract LBA92.

McKay RR et al. IDeate-Prostate01: A phase 3, randomized, open-label study of ifinatamab deruxtecan versus docetaxel in participants with previously treated metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract TPS294.

McKay RR et al. Phase III, randomized, double-blind, placebo-controlled study of adjuvant saruparib (AZD5305) in patients with BRCAm localized high-risk prostate cancer who are receiving radiotherapy and androgen deprivation therapy (EvoPAR-Prostate02). Genitourinary Cancers Symposium 2026;Abstract TPS412.

McKay RR et al. Quality of life, adherence, and adverse events among patients with advanced prostate cancer treated with relugolix: 6-month results of the OPTYX multicenter registry. Genitourinary Cancers Symposium 2026;Abstract 122.

Morgans AK et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. ASCO 2025;Abstract 5004.

Sathekge MM et al. Actinium-225-PSMA radioligand therapy of metastatic castration-resistant prostate cancer (WARMTH Act): A multicentre, retrospective study. Lancet Oncol 2024;25(2):175-83. Abstract

Shore ND et al. Improved survival with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med 2026;394(6):563-75. Abstract

Stein MN et al. Pasritamig, a first-in-class, bispecific T-cell engager targeting human kallikrein 2, in metastatic castration-resistant prostate cancer: A phase I study. J Clin Oncol 2025;43(22):2515-26. Abstract

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.

Yu EY et al. OMAHA-003: Phase 3 trial of CYP11A1 inhibitor opevesostat versus androgen receptor pathway inhibitor (ARPI) switch in participants (pts) with metastatic castration-resistant prostate cancer (mCRPC) after ARPI and taxane-based chemotherapy. Genitourinary Cancers Symposium 2026;Abstract TPS298.