Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

Recruiting Phase 3 Interventional Study
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Other
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) prog…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Inclusion criteria: 1. Age ≥ 18 years, male. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 3. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features. 4. High tumor bur…
Contacts

Shangqian Wang, M.D.,PhD

68303186

wsq5501@126.com

CONTACT