A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Metastatic hormone sensitive prostate cancer;
Disqualifiers
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;
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;
Trial design
Treatments tested in this trial
- Rezvilutamide Tablets
- Enzalutamide Soft Capsules
Treatment groups
206 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov