Actively Recruiting
A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy Versus Enzalutamide Combined With Androgen Deprivation Therapy for Low-volume Metastatic Hormone Sensitive Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-05-11
206
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of rezvilutamide compared to enzalutamide in treating men with low-volume metastatic hormone-sensitive prostate cancer. This phase III, multicenter study focuses on patients with prostate adenocarcinoma who are beginning androgen deprivation therapy and aims to assess their response to these treatments over time. Participants are randomly assigned to receive either oral rezvilutamide tablets or enzalutamide soft capsules, both combined with androgen deprivation therapy. The study is open-label, so both patients and researchers know which treatment is given. The treatment period and evaluations will continue for up to approximately five years to monitor outcomes and safety. During the trial, patients will undergo regular assessments including prostate-specific antigen (PSA) testing, imaging scans to measure tumor progression, and monitoring for side effects. The main outcome measured is the rate of undetectable PSA levels six months after starting treatment. Researchers will also track overall survival, time to disease progression, and adverse events throughout the study. Participation involves scheduled visits and laboratory tests over multiple years, with close monitoring to ensure safety and collect comprehensive data.
CONDITIONS
Brief Title
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Age 18 years or older
- Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- Diagnosed with metastatic hormone-sensitive prostate cancer
- ECOG performance status 0 or 1
- Planned to receive and maintain androgen deprivation therapy during the study
- Adequate liver, kidney, heart, and blood function
- Able to comply with study protocol as determined by the investigator
- Fertile subjects must use effective contraception or abstain from sexual activity and sperm donation until 3 months after last dose of study drug, using condoms plus an additional contraceptive method during treatment and 3 months post-treatment
You will not qualify if you...
- Prior treatment for metastatic prostate cancer including androgen deprivation therapy, chemotherapy, surgery, radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy not allowed except as per protocol
- Previous use or planned use of second-generation androgen receptor antagonists or investigational drugs inhibiting androgen synthesis other than study drugs
- Total PSA already undetectable at baseline
- Use of certain drugs affecting PSA levels within 4 weeks before randomization
- Planned to start other anti-tumor therapies during the study
- Known allergy to rezvilutamide, enzalutamide, or their components
- Unable to swallow or gastrointestinal issues affecting drug absorption
- History of seizure or conditions increasing seizure risk
- Significant cardiovascular disease within 6 months prior to randomization
- Other malignancies within 5 years prior to randomization except allowed by protocol
- Active hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- Any condition that may jeopardize safety or study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 5 years
Participants receive either Rezvilutamide tablets or Enzalutamide soft capsules combined with androgen deprivation therapy to treat metastatic hormone-sensitive prostate cancer.
Regular visits throughout treatment for monitoring and assessments
Trial Site Locations
Total: 1 location
1
The First Medical Center of the Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
D
Daomin Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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