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PEER-TO-PEER CLINICAL CONVERSATIONS
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CAN-2409 in Localized Prostate Cancer: Protocol, Outcomes, and Patient Perspective
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Mark Garzotto, MD, and Tom Hulsey
Dr. Garzotto reviews updated Phase 3 findings evaluating investigational aglatimagene besadenovec (CAN-2409) in combination with radiation therapy, while Tom Hulsey shares the patient perspective. The study regimen included three intraprostatic administrations of aglatimagene besadenovec timed around radiation therapy, each followed by a two-week course of oral valacyclovir.
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PEACE-2 Trial of Cabazitaxel with ADT and Radiotherapy in Very High-Risk Localized Prostate Cancer
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Karim Fizazi, MD, PhD
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| Karim Fizazi presents PEACE-2, a phase 3 2×2 trial enrolling 761 patients with very high-risk localized prostate cancer randomized to ADT plus radiation with or without four cycles of cabazitaxel at 20 to 25 mg/m². With median follow-up exceeding seven years, cabazitaxel did not improve clinical progression-free survival, biochemical progression-free survival, or metastasis-free survival.
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GUNS Trial Examines Biomarker‑Selected Neoadjuvant Approaches in High‑Risk Prostate Cancer
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Martin Gleave, CM, MD, FRCSC, FACS
Matthew Cooperberg speaks with Martin Gleave about GUNS, a neoadjuvant adaptive umbrella trial for men with high-volume, high-grade prostate cancer. Dr. Gleave describes the trial's broader goal of using pathologic response data to guide systemic therapy decisions in advanced prostate cancer.
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| Phase II Trial of Combination Radiation, Hormone, and Immunotherapy in Grade Group 5 Prostate Cancer - Beyond the Abstract
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| Purvish Trivedi, MPH, and Kosj Yamoah, MD, PhD
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| This phase II study shows that adding nivolumab to standard ADT plus ablative-dose radiotherapy is feasible and safe in men with high-volume Grade Group 5 localized prostate cancer, providing early prospective signals of clinical activity in a group with historically poor outcomes. The findings support pursuing multimodal, immune-priming strategies that combine checkpoint inhibition with ablative radiotherapy and ADT, and suggest biomarker-driven selection to identify patients most likely to benefit, warranting validation in larger randomized trials.
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| Perioperative (Neoadjuvant and Adjuvant) Apalutamide + ADT Versus Placebo + ADT with Radical Prostatectomy in High-Risk Localized or Locally Advanced Prostate Cancer: Final Analysis of the PROTEUS Phase 3 Study
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| Mary-Ellen Taplin, MD
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| In the phase 3 PROTEUS trial of 2,109 men with high-risk localized/locally advanced prostate cancer, perioperative apalutamide plus ADT given before and after radical prostatectomy significantly improved pathologic response and metastasis-free survival versus placebo plus ADT, with consistent gains in event-free survival, time to distant metastasis, and time to first subsequent therapy.
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| COACTION: A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide, or Both Prior to Radical Prostatectomy for Intermediate- or High-Risk Prostate Cancer
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| Fernando de Moura, PhD
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| COACTION is a randomized, open-label, multicenter phase II trial comparing neoadjuvant darolutamide + leuprorelin versus either agent alone for 24 weeks before radical prostatectomy in 144 men with unfavorable intermediate- or high/very high-risk nonmetastatic prostate cancer, with the primary endpoint of minimal residual disease.
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| Clinico-Transcriptomic Risk Stratification to Guide Abiraterone Treatment Intensification in High-Risk Prostate Cancer: A Combined Analysis of NRG/RTOG 9202, 9413, 9902, and 0521
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| Krishnan Patel, MD
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| Krishnan Patel discusses a combined analysis of four NRG/RTOG trials, in which a 22-gene genomic classifier independently improved prediction of metastasis-free survival, distant metastasis, and overall survival beyond clinical risk, and about 25% of patients had discordant clinical and genomic risk, supporting integrated risk assessment.
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