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NCT02987543 · ClinicalTrials.gov registry record · Phase 3
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 387
- Enrollment target
NCT02987543: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02987543 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 387 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02987543, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 387 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
Primary Outcome
The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a \>=20% incre
Interventions
- DRUG enzalutamide
- DRUG abiraterone acetate
- DRUG olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 3 |
What the finished NCT02987543 record still lists
NCT02987543 is an interventional study that assigns participants to a tested intervention. The registered 387 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 (50% lower).
The record links to 0 conditions, and to 3 interventions - of which enzalutamide is the first listed.
NCT02987543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02987543 about?
NCT02987543 is a clinical study titled "Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)". The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
What is the current status of trial NCT02987543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 387 participants. The study started on 2017-02-06. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT02987543?
The interventions under investigation include: enzalutamide (DRUG), abiraterone acetate (DRUG), olaparib (DRUG).
Who is sponsoring clinical trial NCT02987543?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02987543's enrollment target sits among peer trials
387 973rd of 2000 higher than 1,028 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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