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NCT03279250 · ClinicalTrials.gov registry record · Phase 2
Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT03279250: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03279250 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03279250, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
Primary Outcome
The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.
Interventions
- DRUG Apalutamide
- PROCEDURE Radical Prostatectomy
- DRUG Prednisone
- DRUG Abiraterone Acetate
- BIOLOGICAL Gonadotropin-releasing Hormone Analog
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2021-05-11 |
| Phase | Phase 2 |
What the finished NCT03279250 record still lists
NCT03279250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 5 interventions - of which Apalutamide is the first listed.
NCT03279250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03279250 about?
NCT03279250 is a clinical study titled "Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer". This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or b...
What is the current status of trial NCT03279250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2017-10-13. Estimated completion is 2021-05-11.
What interventions are being tested in trial NCT03279250?
The interventions under investigation include: Apalutamide (DRUG), Radical Prostatectomy (PROCEDURE), Prednisone (DRUG), Abiraterone Acetate (DRUG), Gonadotropin-releasing Hormone Analog (BIOLOGICAL).
Who is sponsoring clinical trial NCT03279250?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03279250's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 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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