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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 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 108 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04523207
The ClinicalTrials.gov registry entry for NCT04523207 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT04523207 reports 0 study locations.
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.
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