Trials / Active Not Recruiting
Active Not RecruitingNCT04108208
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apalutamide | Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily. |
| DRUG | Placebo | Matching placebo will be administered orally. |
| DRUG | Androgen-deprivation Therapy (ADT) | Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated. |
Timeline
- Start date
- 2019-12-17
- Primary completion
- 2023-06-01
- Completion
- 2026-06-05
- First posted
- 2019-09-30
- Last updated
- 2026-04-13
- Results posted
- 2025-03-28
Locations
27 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04108208. Inclusion in this directory is not an endorsement.