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NCT03009981 · ClinicalTrials.gov registry record · Phase 3
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
A Phase 3 study, sponsored by Alliance Foundation Trials.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
NCT03009981: Completed Phase 3 study, sponsored by Alliance Foundation Trials.
NCT03009981 is a Phase 3 study that has completed, run by Alliance Foundation Trials. The registered enrollment target is 504 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03009981, a Phase 3 study, has completed, sponsored by Alliance Foundation Trials.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
Study Summary
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
Primary Outcome
To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).
Interventions
- DRUG Apalutamide
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG LHRH Analogue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2017-03-06 |
| Est. Completion | 2025-06-25 |
| Phase | Phase 3 |
What the finished NCT03009981 record still lists
NCT03009981 is an interventional study that assigns participants to a tested intervention. The registered 504 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 (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Apalutamide is the first listed.
NCT03009981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03009981 about?
NCT03009981 is a clinical study titled "A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer". This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
What is the current status of trial NCT03009981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2017-03-06. Estimated completion is 2025-06-25.
What interventions are being tested in trial NCT03009981?
The interventions under investigation include: Apalutamide (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG), LHRH Analogue (DRUG).
Who is sponsoring clinical trial NCT03009981?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03009981's enrollment target sits among peer trials
504 742nd of 2000 higher than 1,258 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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