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NCT05884398 · ClinicalTrials.gov registry record · Phase 3
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
A Phase 3 study of Metastatic Castrate-sensitive Prostate Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT05884398: Active Phase 3 study of Metastatic Castrate-sensitive Prostate Cancer, sponsored by Janssen Research & Development.
NCT05884398 is a Phase 3 study of Metastatic Castrate-sensitive Prostate Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05884398, a Phase 3 study of Metastatic Castrate-sensitive Prostate Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
Primary Outcome
rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] and 99mTc bone scans).
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Androgen-deprivation Therapy (ADT)
Study Locations (20)
California
- Urology Associates of Central California - Fresno
- VA Medical Center - San Francisco
- Sansum Clinic Pharm - Santa Barbara
New Jersey
- MSKCC Basking Ridge - Basking Ridge
- MSKCC Monmouth - Middletown
- MSKCC Bergen - Montvale
Arizona
- Del Sol Research Management, LLC - Tucson
- Arizona Urology Specialists - Tucson
Illinois
- Associated Urological Specialists LLC - Chicago Ridge
- Advanced Urology Associates - Joliet
Indiana
- Urology of Indiana - Greenwood
- First Urology, PSC - Jeffersonville
Maryland
- Maryland Oncology Hematology P A - Silver Spring
- Chesapeake Urology Research Associates - Towson
Alabama
- Urology Centers Of Alabama - Homewood
Arkansas
- Arkansas Urology - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2028-10-12 |
| Phase | Phase 3 |
What the registry record for NCT05884398 still lists
NCT05884398 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Metastatic Castrate-sensitive Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Apalutamide is the first listed.
NCT05884398 names 20 study sites across 12 states, led by California, New Jersey, Arizona.
Frequently Asked Questions
What is clinical trial NCT05884398 about?
NCT05884398 is a clinical study titled "A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC". The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with ...
What is the current status of trial NCT05884398?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2023-08-31. Estimated completion is 2028-10-12.
What conditions does trial NCT05884398 study?
This clinical trial studies the following conditions: Metastatic Castrate-sensitive Prostate Cancer.
What interventions are being tested in trial NCT05884398?
The interventions under investigation include: Apalutamide (DRUG), Androgen-deprivation Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT05884398?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05884398 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05884398's enrollment target sits among peer trials
420 891st of 2000 higher than 1,102 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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