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Highlights from the 2021 American Society of Clinical Oncology Annual Meeting
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| Poster Session - Prostate |
| A Phase III Trial of Docetaxel Versus Docetaxel and Radium-223 in Patients With mCRPC: DORA
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| Michael J. Morris, MD
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| Michael Morris reviewed the trial design for a phase III study to determine the clinical benefit docetaxel versus docetaxel and Radium-223 in patients with mCRPC, the DORA trial. The study is open at 32 sites in the US and Netherlands and has 170 subjects enrolled.
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| TALAPRO-2: A Phase 3 Randomized Study of Enzalutamide plus Talazoparib Versus Placebo in Patients with New mCRPC |
| Neeraj Agarwal, MD |
| Neeraj Agarwal discussed the TALAPRO-2 trial, a phase 3, two-part study evaluating the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of talazoparib plus enzalutamide in patients with mCRPC with or without DNA damage repair alterations. |
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| Radium-223 Versus Novel Antihormone Therapy for Progressive mCRPC After 1 Line of NAH: RADIANT, an International Phase 4, Randomized, Open-Label Study |
| Karim Fizazi, MD, Ph.D. |
| At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Karim Fizazi presented details of the RADIANT trial. This study has been designed to assess radium-223 outcomes in patients with mCRPC that progressed after prior treatment with NAH and docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC. |
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| Real-World Treatment Patterns Among Patients Diagnosed with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) in Community Oncology Settings |
| Daniel George, MD |
| Daniel George presented an assessment of the real-world utilization of effective combination therapies in the first-line treatment of mCSPC in oncology practice. Based on the data, even in 2019, the majority of patients with mCSPC treated in real-world settings do not receive intensified treatment regimes that have been prove to improve overall survival in randomized controlled trials. Further, those that did receive these treatments had shorter durations of treatment than were seen in registration trials. |
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| Darolutamide Tolerability from Extended Follow up and Treatment Response in the Phase 3 ARAMIS Trial |
| Karim Fizazi, MD, Ph.D. |
| Karim Fizazi presented results of tolerability from extended follow-up and treatment response analyses from the ARAMIS trial. Darolutamide remained well tolerated with extended treatment at the recommended dose of 600 mg twice daily, which allows patients to maintain their quality of life long term. Long-term treatment with darolutamide extends survival and delays disease progression in men with nmCRPC. |
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| Radiation and Androgen Deprivation Therapy with or Without Docetaxel in the Management of Non-Metastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial |
| Anthony D'Amico, MD, Ph.D. |
| Anthony D’Amico presented results of a randomized controlled trial examining the role of docetaxel with radiation therapy and androgen deprivation therapy in men with non-metastatic unfavorable-risk prostate cancer. The authors concluded that the addition of docetaxel to ADT and radiotherapy in men with unfavourable risk prostate cancer did not improve overall survival, though there may be a beneficial effect among men with PSA <4 ng/mL due to decreased prostate cancer related mortality, though this is a post-randomization, hypothesis-generating observation. |
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| Interim Results of AASUR: A Single Arm, Multi-Center Phase 2 Trial of Apalutamide + Abiraterone Acetate + Prednisone + Leuprolide With Stereotactic Ultra-Hypofractionated Radiation in Very High Risk, Node Negative Prostate Cancer |
| Sean McBride, MD, MPH |
| Sean McBride presented data examining whether short-term intensification of androgen deprivation through the use of apalutamide and abiraterone acetate in addition to leuprolide with prostate radiotherapy would improve cancer control and minimize morbidity. |
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| Is There a Role for Systemic Therapy Intensification With Radiotherapy in Locally Advanced Prostate Cancer?
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| Neha Vapiwala, MD, FACR
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| Neha Vapiwala provided a discussant overview of these data and helped to contextualize how we may apply them to our practices in the Prostate, Testicular, Penile Poster Discussion session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
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| Impact of Age on Efficacy and Safety of Relugolix: A Subgroup Analysis from the Randomized, Phase 3 HERO Study Versus Leuprolide in Men with Advanced Prostate Cancer |
| Michael Cookson, MD, MMHC |
| Michael Cookson presented the results of their study further characterizing the impact of age on the use of relugolix in advanced prostate cancer from the HERO study. In this subgroup analysis of the HERO study, relugolix was effective regardless of age, and the benefit/risk profile remained favorable for relugolix compared with leuprolide, consistent with the overall population. |
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| ODENZA: A French Prospective, Randomized, Open-Label, Multicenter, Cross-over Phase II Trial of Preference Between Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-Resistant Prostate Cancer
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| Emeline Colomba, MD
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| Emeline Colomba presented results of the ODENZA trial to assess whether differences in toxicity affect patient preference among those with early mCRPC. A numerically greater number of patients with early mCRPC preferred darolutamide compared with enzalutamide, though this was not significantly different. Fatigue was a key factor influencing patient preference.
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| Phase 1b Study of AMG 757, a Half-Life Extended Bispecific T-Cell Engager Targeting DLL3, in De Novo or Treatment Emergent Neuroendocrine Prostate Cancer |
| Rahul Aggarwal, MD |
| Rahul Aggarwal presented the design of NCT04702737, an open-label, phase 1b study evaluating AMG 757 infusion in patients with metastatic de novo or treatment-emergent NEPC. This study comprises two phases: dose exploration and then dose expansion. |
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| Interim PSMA PET/CT for Response Evaluation During LuPSMA Treatment in mCRPC (INTERIM PET): An Explorative, Multicenter Study |
| Andrei Gafita, MD |
| Andrei Gafita presented work evaluating the prognostic value of an interim PSMA PET/CT in men with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA and to develop a novel framework for Response Evaluation Criteria In PSMA-imaging (RECIP). |
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| MRI and Targeted Biopsies Compared to Transperineal Mapping Biopsies For Targeted Ablation In Recurrent Prostate Cancer After Radiotherapy: The FORECAST Trial
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| Taimur T. Shah, MBBS, BSc (Hons), FRCS (Urol), Ph.D.
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| At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Taimur Shah presented the results of the FORECAST trial, examining MRI and targeted biopsy compared to transperineal biopsy to inform ablation for recurrent prostate cancer following initial radiotherapy.
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| The CADMUS Trial: Comparing mpMRI Ultrasound Targeted Biopsies With mpMRI Targeted Biopsies in the Detection of Clinically Significant Prostate Cancer
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| Alistair Grey
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| Alistair Grey presented the results of the CADMUS trial, a study comparing prostate biopsy informed by multiparametric ultrasonography and by multiparametric MRI. This CADMUS trial demonstrated that mpUSS has a diagnostic performance approaching that of mpMRI. Further, the combination of both approaches increases the detection of clinically significant cancer over mpMRI alone.
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| Have We Optimized the Detection and Risk Stratification in Men With Localized Prostate Cancer?
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| Samir Taneja, MD
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| Following three presentations regarding both radiologic and genomic approaches for prostate cancer diagnosis and risk stratification Dr. Samir Taneja provided a discussant overview of these data and helped to contextualize how we may apply them to our practices.
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| To view our full coverage of the 2021 ASCO Annual Meeting, visit the Conference Coverage section on UroToday.com
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