Actively Recruiting
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-08-09
200
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
CONDITIONS
Official 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...
- Males aged 40 to 80 years
- Histologically or cytologically confirmed prostate adenocarcinoma
- Presence of metastatic disease
- Eligible for androgen deprivation therapy (ADT) and docetaxel
- Started or not started first-generation ADT within 12 weeks before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Laboratory requirements: neutrophils 1.5x10^9/L, platelets 100x10^9/L, hemoglobin 9 g/dL, serum creatinine 1.5x upper limit of normal, AST and ALT 2.5x upper limit of normal, total bilirubin 1.5x upper limit of normal, INR <1.5
- High tumor burden defined by either 4 bone metastatic lesions with at least one outside pelvis or spine, or visceral metastatic lesions on CT/MRI (excluding lymph nodes)
You will not qualify if you...
- Prior use of LHRH agonists/antagonists, second-generation AR inhibitors, CYP17 enzyme inhibitors, chemotherapy, or immunotherapy for prostate cancer before randomization
- Radiation therapy or radiopharmaceutical treatment within 2 weeks before randomization
- History of stroke, myocardial infarction, severe/unstable angina, bypass surgery, or congestive heart failure (NYHA class III or IV) within 6 months before randomization
- Previous malignancy except treated basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer not invading muscle, or any cancer in complete remission for 5 years
- Gastrointestinal diseases or procedures expected to interfere with drug absorption
- Inability to take oral medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
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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