Actively Recruiting
A Randomized Controlled Study Comparing Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide+ADT in Metastatic Hormone-Sensitive Prostate Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-08-09
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding docetaxel chemotherapy to a combination of Rezvilutamide and androgen deprivation therapy (ADT) improves overall survival in men with metastatic hormone-sensitive prostate cancer (mHSPC). This phase 3 randomized controlled study aims to evaluate the value of chemotherapy alongside next-generation androgen receptor inhibitors in patients with a high tumor burden. Participants will be randomly assigned to one of two groups: one receiving Rezvilutamide (240 mg daily tablets) plus ADT and docetaxel chemotherapy for 6 cycles, and the other receiving Rezvilutamide plus ADT without chemotherapy. Rezvilutamide is taken orally once daily, with or without food. Treatment is studied over a planned period with careful monitoring of effects and safety. During the study, participants will undergo assessments including laboratory tests to monitor blood counts, kidney and liver function, and coagulation. Researchers will measure outcomes such as radiographic progression-free survival over 36 months, prostate-specific antigen (PSA) response rate, and time to castration-resistant prostate cancer. The study includes regular follow-ups to monitor health status and treatment response throughout the trial period.
CONDITIONS
Brief Title
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 40 to 80 years
- Histologically or cytologically confirmed prostate adenocarcinoma
- Metastatic disease with high tumor burden
- Eligible for androgen deprivation therapy (ADT) and docetaxel chemotherapy
- Started or not started first-generation ADT within 12 weeks before randomization
- ECOG performance status of 0 or 1
- Laboratory tests meeting minimum hematology, renal, liver, and coagulation requirements
- Bone scan showing 4 or more bone metastatic lesions including at least one outside pelvis or spine, or CT/MRI showing visceral metastatic lesions excluding lymph nodes
You will not qualify if you...
- Prior use of LHRH agonists/antagonists or second-generation androgen receptor inhibitors
- Previous chemotherapy or immunotherapy for prostate cancer before randomization
- Radiation therapy or radiopharmaceutical treatment within 2 weeks before randomization
- History of stroke, myocardial infarction, severe or unstable angina, bypass surgery, or congestive heart failure class III or IV within 6 months before randomization
- Previous malignancy except certain treated skin or superficial bladder cancers or cancers in remission for 5 years
- Gastrointestinal conditions affecting study drug absorption
- Inability to take oral medication
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 36 months
Participants receive either Rezvilutamide combined with androgen deprivation therapy (ADT) and docetaxel chemotherapy, or Rezvilutamide combined with ADT only, to treat metastatic hormone-sensitive prostate cancer.
Regular visits during treatment cycles including 6 cycles of docetaxel for applicable participants
Trial Site Locations
Total: 1 location
1
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
S
Shangqian Wang, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here