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PEER-TO-PEER CLINICAL CONVERSATIONS |
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Evaluating the Efficacy of Sabizabulin in The Treatment of Metastatic Castration-Resistant Prostate Cancer
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Robert Dreicer, MD, MS, MACP, FASCO
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| Joining Alicia Morgans is Robert Dreicer highlighting a currently enrolling Phase III trial of sabizabulin, an oral cytoskeleton disruptor in mCRPC. The VERACITY trial s a blinded trial of 245 patients randomized to two to one drug, to the alternative ARI. Dr. Dreicer describes the rationale for the trial, the trial design, and the eligibility criteria.
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PSMAfore Trial - Evaluating 177Lu-PSMA-617 in Chemotherapy-Naïve mCRPC Patients
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Michael Morris, MD
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| Alicia Morgans and Michael Morris discuss the PSMAfore trial in progress. PSMAfore is a phase 3 study evaluating the patient population that just precedes VISION in terms of place on the timeline of metastatic CRPC. This trial is designed for following treatment with an androgen receptor pathway inhibitor, and patients with chemotherapy-naive, and mCRPC.
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| A Trial of VERU-100 for the Treatment of Advanced Prostate Cancer |
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Ronald Tutrone, MD, FACS, CPI
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| Alica Morgans is joined by Ronald Tutrone to provide an update on the clinical trial VERU 100. VERU‑100 is a novel, proprietary long-acting gonadotropin-releasing hormone (GnRH) antagonist peptide 3-month subcutaneous depot formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT). |
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Intensive Androgen Deprivation in High-Risk Biochemically Recurrent Prostate Cancer Patients - Alliance Foundation Trial (AFT19)
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Rahul Aggarwal, MD
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| Joining Alicia Morgans to highlight The Alliance Foundation (AFT-19) trial is Rahul Aggarwal. The AFT-19 trial started enrolling in March 2017 and is looking at intensive androgen deprivation therapy (ADT) in high-risk biochemically recurrent prostate cancer (BCRP) patients.
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Evaluating the Benefit of Rucaparib and Enzalutamide Combination Therapy Vs. Enzalutamide Alone for the Treatment of mCRPC - the Phase III CASPAR Trial
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Arpit Rao, MD, MBBS
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| The University of Minnesota has recently launched the CASPAR randomized Phase III clinical trial of enzalutamide and rucaparib versus enzalutamide and placebo in first-line metastatic castrate-resistant prostate cancer (CRPC). Alicia Morgans is joined by Arpit Rao from the University of Minnesota to discuss the launch and the initial success of this new trial.
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| PSMAfore: A Phase 3 Study To Compare 177Lu-PSMA-617 Treatment With a Change in Androgen Receptor Pathway Inhibitor in Taxane-Naïve Patients With mCRPC |
| Michael Morris, MD |
| Michael Morris provides a summary of the PSMAfore trial in progress. This study examines the role of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) in taxane-naïve patients with mCRPC. The study will assess the primary endpoint of rPFS according to PCWG3-modified RECIST v1.1 criteria. |
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| PSMAddition: A Phase 3 Trial to Compare Treatment with 177Lu-PSMA-617 plus Standard of Care (SOC) Versus SOC Alone in Patients with Metastatic Hormone-Sensitive Prostate Cancer
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| Scott Tagawa, MD
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| Scott Tagawa presents a trial in progress summary of the PSMAddition trial. This trial was launched given the proven benefits of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617). PSMAddition is an international prospective open-label, randomized, phase III trial in adult men with mHSPC, with a primary endpoint of radiographic progression-free survival.
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| A Prospective Validation of the Genomic Classifier To Define High-Metastasis Risk in a Subset of African American Men With Early Localized Prostate Cancer: VanDAAM Study
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| Kosj Yamoah, MD, Ph.D.
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| Kosj Yamoah presents the results of the VanDAAM study, a prospective study validating the genomic classifier to identify patients with a high risk of metastasis among African American men with early localized prostate cancer. Based on the data, the standard clinicopathologic assessment using NCCN criteria often provides suboptimal risk stratification for African American men with prostate cancer.
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| Pembrolizumab plus Docetaxel and Prednisone in Patients with Abiraterone Acetate– or Enzalutamide–Pretreated Metastatic Castration-Resistant Prostate Cancer: KEYNOTE-365 Cohort B Update |
| Emanuela Romano, MD |
| Emanuela Romano presents the updated results after additional enrollment and longer follow-up from cohort B of the KEYNOTE-365 trial. This updated data confirms prior presented data suggesting clinical activity of the combination of docetaxel plus pembrolizumab in patients who had progressed on anti-androgen therapy with either enzalutamide or abiraterone. |
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| First-in-Human Phase 1 Study of ARV-110, an Androgen Receptor PROTAC Degrader in Patients with Metastatic Castration-Resistant Prostate Cancer Following Enzalutamide and/or Abiraterone Acetate Treatment |
| Daniel Petrylak, MD |
| In this presentation, Daniel Petrylak, MD, and colleagues present results from a first-in-human phase I study of ARV-110 in patients with metastatic castration-resistant prostate cancer (mCRPC) who experienced rising PSA or 2+ new lesions on bone scan after at least two prior systemic therapies, one of which was abiraterone or enzalutamide. |
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| Phase I Study of CCW702, A Bispecific Small Molecule-Antibody Conjugate Targeting PSMA and CD3 in Patients with mCRPC
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| Mark C. Markowski, MD
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| Preclinical data suggest efficacy in the xenograft model, with near complete bioavailability when administered subcutaneously at 66 ug/kg. The design of CCW702 was leveraged to optimize the structure and function of T cell redirected cytotoxicity against PSMA-positive prostate cancer tumors in preclinical development. At the 2021 ASCO virtual annual program, Mark Markowski discussed the design of this phase I trial. |
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| Study Evaluating Metastatic Castrate-Resistant Prostate Cancer Treatment Using 177Lu-PNT2002 PSMA Therapy After Second-Line Hormonal Treatment (SPLASH)
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| Kim Chi, MD
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| Kim Chi presents the design of the SPLASH trial which seeks to prospectively evaluate the efficacy of 177Lu-PNT2002 for men with progressive mCRPC after androgen receptor axis-targeted (ARAT) therapy. This study evaluates metastatic castrate-resistant Prostate cancer using 177LU-PNT2002 PSMA therapy after second line hormonal treatment (SPLASH), is a multi-center, open-label, phase III study, and is currently enrolling in Canada and the United States.
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