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NCT01751451 · ClinicalTrials.gov registry record · Phase 2
3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT01751451: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01751451 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751451, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
Primary Outcome
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (\>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Interventions
- DRUG Degarelix
- DRUG Abiraterone acetate
- DRUG Abiraterone acetate plus degarelix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2012-12-18 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 2 |
What the finished NCT01751451 record still lists
NCT01751451 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Degarelix is the first listed.
NCT01751451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751451 about?
NCT01751451 is a clinical study titled "3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy". In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 20...
What is the current status of trial NCT01751451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2012-12-18. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT01751451?
The interventions under investigation include: Degarelix (DRUG), Abiraterone acetate (DRUG), Abiraterone acetate plus degarelix (DRUG).
Who is sponsoring clinical trial NCT01751451?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751451's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 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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