Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Recruiting Phase 3 Interventional Study
Metastatic Prostate Cancer Hormone Sensitive Prostate Cancer Chemotherapy Effect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 80
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Males aged ≥40 years and ≤80 years. 2. Histologically or cytologically confirmed prostate adenocarcinoma. 3. Metastatic disease. 4. Eligible for ADT and Docetaxel. 5. Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before…
Contacts

Shangqian Wang, M.D., Ph.D.

+862568303186

wsq5501@126.com

CONTACT