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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01751451
The ClinicalTrials.gov registry entry for NCT01751451 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Degarelix is the first listed.
NCT01751451 reports 0 study locations.
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.
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