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NCT04523207 · ClinicalTrials.gov registry record · Phase 2
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT04523207: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04523207 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523207, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
Primary Outcome
Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA \> 0.2 ng/mL (including those who were lost to fo
Interventions
- DRUG Apalutamide
- DRUG Relugolix
- DRUG ADT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2023-10-25 |
| Phase | Phase 2 |
What the finished NCT04523207 record still lists
NCT04523207 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT04523207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04523207 about?
NCT04523207 is a clinical study titled "A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases". Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co ad...
What is the current status of trial NCT04523207?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2020-08-19. Estimated completion is 2023-10-25.
What interventions are being tested in trial NCT04523207?
The interventions under investigation include: Apalutamide (DRUG), Relugolix (DRUG), ADT (DRUG).
Who is sponsoring clinical trial NCT04523207?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04523207's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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