Actively Recruiting
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-05-11
206
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- Diagnosed with metastatic hormone-sensitive prostate cancer
- ECOG performance status of 0-1
- Planned to receive and maintain androgen deprivation therapy during the study
- Adequate liver, kidney, heart, and blood function
- Able to comply with the study protocol
- Fertile participants must use effective contraception or abstain from sexual activity and sperm donation during and for 3 months after treatment
- Use condoms plus another effective contraceptive method during sexual activity with fertile female partners throughout treatment and for 3 months after
You will not qualify if you...
- Prior treatment with ADT, chemotherapy, surgery, radiation, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as allowed
- Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or investigational androgen synthesis inhibitors
- PSA levels already undetectable at baseline
- Participation in interventional trials or treatment with certain drugs lowering PSA 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 have conditions affecting drug absorption
- History or risk factors for seizures
- Significant cardiovascular disease within 6 months before randomization
- Any other cancer within 5 years prior, except as allowed
- Active hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- Any condition that could risk safety, affect study results, or ability to complete the study, such as uncontrolled hypertension, severe diabetes, or neurological or psychiatric disorders
AI-Screening
AI-Powered Screening
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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
CONTACT
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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