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 (May 2026). This Phase 3 trial studies multiple treatments including Docetaxel and Rezvilutamide for metastatic prostate cancer.

Phase 3RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT05983783Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

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.

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