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Session Highlights from the 2021 Annual Meeting
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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 T. Tagawa, MD
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| Scott Tagawa presented a trial in progress summary of the PSMAddition trial. This trial was launched given the proven benefits of [177Lu]Lu-PSMA-617. The primary endpoint of the PSMAddition trial is radiographic progression-free survival (rPFS), as assessed by blinded independent centralized review. Following centrally confirmed radiographic progression, cross-over is allowed for participants in the control arm to the 177Lu-PSMA-617 arm.
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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 |
In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Michael Morris provided a summary of the PSMAfore trial in progress. The authors will assess the primary endpoint of rPFS according to PCWG3-modified RECIST v1.1 criteria. Following blinded independent centrally confirmed radiographic progression, patients in the ARPI arm can crossover to the 177Lu-PSMA-617 arm.
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| Final Results of Phase I/II Trial of Fractionated Dose 177Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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| Scott T. Tagawa, MD
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| Scott Tagawa reported the results of a phase I/II dose-escalation study of a fractionated (dose-dense) treatment regime of 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC). Previously reported, the initial phase I data from this study demonstrated no evidence of short-term dose-limiting toxicity.
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| Clinical and Cost Impact of Cabazitaxel vs a Second Androgen Receptor Targeted Agent for Patients With mCRPC Previously Treated With Docetaxel and the Alternative ARTA (Abiraterone or Enzalutamide)
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| Alicia Morgans, MD, MPH
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| Alicia Morgans discusses a modeling analysis of cabazitaxel compared to repeat treatment with an androgen receptor targeting agent (ARTA) among patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel and the alternative ARTA.
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| Patient-Reported Pain in Men With Metastatic Castration-Resistant Prostate Cancer Receiving Talazoparib: TALAPRO-1
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| Fred Saad, MD, FRCS
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| Fred Saad presented a secondary analysis of the change in patient-reported pain among patients treated with rucaparib for metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-1 trial. Talazoparib improved pain burden in men with mCRPC harboring HRR/DDR alterations pretreated with taxanes and NHT.
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| Health-Related Quality of Life at Final Analysis of the GALAHAD Study of Niraparib in Patients With Metastatic Castration-Resistant Prostate Cancer and DNA Repair Defects
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| Matthew Smith, MD, Ph.D.
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| Matthew Smith presented an analysis of patient-reported health-related quality of life (HRQoL) based on the phase II open-label GALAHAD study of niraparib in mCRPC patients with DNA repair defects (DRD) who had progressed on prior taxane-based chemotherapy and androgen signaling inhibitor therapy.
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| Safety of Tazemetostat in Combination With Abiraterone/Prednisone or Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
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| Wassim Abida, MD, Ph.D.
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| Wassim Abida presented an analysis of the safety and efficacy of tazemetostat in combination with abiraterone and prednisone or enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The phase Ib component of this trial demonstrates that toxicity was consistent with the known adverse events of each of these agents. Further, there is preliminary evidence of efficacy which will be further assessed in the phase II component which is actively enrolling.
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| PRORADIUM: Prospective Analysis of the Impact of Germline Mutations in Homologous Recombination Genes on the Response to Radium-223 for Metastatic Castration-Resistant Prostate Cancer
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| Elena Castro, MD
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| Elena Castro presented the results from the PRORADIUM cohort examining the effect of germline mutations on outcomes for patients treated with radium-223. Based on the data, germline mutations in HR genes are associated with improved ALP response and a trend towards more prolonged OS, particularly those with gATM mutations.
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| Role of Serum Biomarkers of Bone Metabolism in mCRPC Patients Treated with Radium-223: PRORADIUM Study Final Results
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| Nuria Romero-Laorden, MD, Ph.D.
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| Nuria Romero-Laorden discusses the final results of PRORADIUM, a study assessing the role of serum biomarkers of bone metabolism in mCRPC patients treated with radium-223. Dr. Romero-Laorden highlights that baseline serum markers of bone formation may serve as biomarkers for prognosis in mCRPC patients treated with radium-223, however that validation analysis will be needed to confirm these results.
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| Pain Efficacy With Radium-223 in the REASSURE Global, Prospective, Observational Study of Men With Metastatic Castration-Resistant Prostate Cancer |
| Celestia S. Higano, MD, FACP |
| Celestia Higano presented a real-world analysis of pain efficacy of radium-223 treatment among patients with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases. Using these real-world data, patients with pain at baseline who received treatment with Radium-223 experienced an incremental reduction in pain with each cycle, regardless of baseline EOD or concomitant opioid/EBRT use. |
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| Bipolar Androgen Therapy (BAT) Plus Olaparib in Men With Metastatic Castration-Resistant Prostate Cancer
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| Michael Schweizer, MD
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| Michael Schweizer described a single-center phase II trial testing olaparib in combination with Bipolar Androgen Therapy (BAT) for men with metastatic castration-resistant prostate cancer (mCRPC). BAT plus olaparib was associated with high response rates and long PFS in patients with mCRPC. Notably, clinical benefit was observed regardless of HRR gene mutational status.
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| Geographical Assessment of Efficacy and Safety of Relugolix: A Subgroup Analysis from the Randomized, Phase 3 HERO Study vs Leuprolide in Men with Advanced Prostate Cancer
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| Bertrand Tombal, MD, Ph.D.
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| Bertrand Tombal presents the results characterizing the geographical impact on the efficacy and safety of relugolix versus leuprolide in advanced prostate cancer. In this HERO study subgroup analysis, relugolix was well tolerated and effective across all geographical locations of men. These results are consistent with those of the overall population where relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a similar overall safety and tolerability profile in the two groups.
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| Efficacy and Safety of Relugolix vs Leuprolide in Men with Advanced Prostate Cancer: Clinical Subgroup Analysis from the Phase 3 HERO Study
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| Bertrand Tombal, MD, Ph.D.
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Bertrand Tombal presented the results of a subgroup analysis undertaken to further evaluate relugolix treatment for various clinical subgroups included in the HERO study. Treatment with relugolix was associated with improved castration rates versus leuprolide in men with a broad range of clinical presentations for advanced prostate cancer.
Treatments were generally well-tolerated across the subgroups analyzed.
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| Objective Computerized Cognitive Assessment in Men with Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Randomly Receiving Darolutamide or Enzalutamide in the ODENZA Trial
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| Emeline Colomba, MD
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| Emeline Colomba presented the results from the ODENZA trial comparing darolutamide and enzalutamide, with a focus on cognitive assessment. Each of these agents is a next-generation androgen receptor inhibitor. However, darolutamide does not significantly penetrate the blood-brain barrier, which may reduce cognitive impairment.
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| To view our full coverage of the 2021 ESMO Annual Congress, visit the Conference Coverage section on UroToday.com |
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