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.
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
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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
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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…
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