Trial reportClinical and translational medicine2026
Rezvilutamide plus docetaxel in chemotherapy-naive metastatic castration-resistant prostate cancer patients after progression on abiraterone: A multi-centre, open-label, phase II trial.
Trial report in Clinical and translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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17 authors.
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Abstract
backgroundA multi-centre, 2-part, phase II study assessed adding rezvilutamide (a novel androgen receptor antagonist) to docetaxel in abiraterone-refractory, metastatic castration-resistant prostate cancer (mCRPC) patients who were naive to chemotherapy. Herein, we report results from part 1.
methodsPart 1 encompassed both dose-escalation and dose-expansion phases. Eligible patients received oral rezvilutamide (160/240 mg, once daily [QD]) plus intravenous docetaxel (75 mg/m
resultsFrom 2, December 2020, to 5, August 2021, 36 patients were eligible for enrolment (18 patients with rezvilutamide 160 mg plus docetaxel and 18 patients with rezvilutamide 240 mg plus docetaxel). No one experienced dose-limiting toxicity. 32 (88.9%) patients experienced grade 3 or higher treatment-related adverse events. At week 12, 67.7% of the 31 evaluable patients showed a response in prostate-specific antigen (PSA) levels. Among all 36 patients, the median times were 10.5 months (95% CI: 5.6-14.1) for PSA progression, 13.8 months (95% CI: 8.4-19.2) for radiological progression-free survival and 16.2 months (95% CI: 12.9-22.5) for overall survival. The limitations were a small sample size and a non-randomised design.
conclusionsRezvilutamide plus docetaxel followed by maintenance with rezvilutamide monotherapy demonstrated good tolerability and promising efficacy in chemotherapy-naive, abiraterone-refractory, mCRPC patients.
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