OncoMatch/Clinical Trials/NCT05983783
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
Is NCT05983783 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Docetaxel and Rezvilutamide for metastatic prostate cancer.
Treatment: Docetaxel · Rezvilutamide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Endocrine / hormonal
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: LHRH agonist
Prior use of LHRH agonists
Cannot have received: LHRH antagonist
Prior use of LHRH antagonists
Cannot have received: second-generation androgen receptor inhibitor (enzalutamide, ARN-509, darolutamide (ODM-201))
second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors
Cannot have received: CYP17 enzyme inhibitor (abiraterone acetate, oral ketoconazole)
CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer
Cannot have received: chemotherapy
chemotherapy for prostate cancer prior to randomization
Cannot have received: immunotherapy
immunotherapy for prostate cancer prior to randomization
Lab requirements
Blood counts
neutrophils ≥1.5×10^9/l, platelets ≥100×10^9/l, hemoglobin ≥9g/dl
Kidney function
serum creatinine ≤1.5× upper limit of normal (uln)
Liver function
ast and alt ≤2.5× uln, total bilirubin (tbil) ≤1.5× uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05983783 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 40 years old.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages