A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostat… (NCT07241416) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
China206 participantsStarted 2025-12-05
Plain-language summary
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;
✓. Age ≥ 18 years;
✓. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;
✓. Planned to receive and maintain ADT during the study period;
✓. Adequate hepatic, renal, heart, and hematological functions;
✓. Determined by the investigator to be able to comply with the study protocol;
Exclusion criteria
✕. Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;
✕. Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;
✕. Total PSA has decreased to undetectable levels at baseline;
✕
What they're measuring
1
Prostate Specific Antigen (PSA) undetectable rate based on central laboratory.
. Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;
✕. Planned to initiate any other anti-tumor therapies during the study;
✕. Known history of hypersensitivity to rezvilutamide, enzalutamide, or any of their components;
✕. Unable to swallow, chronic diarrhea or intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
✕. History of seizure or certain conditions that may predispose to seizure;