CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Abiraterone acetate +2 moredrug
Likely dose
Abiraterone acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01751451
NCT01751451Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, 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

Memorial Sloan Kettering Cancer Center·interventional·Posted Dec 18, 2012·Updated Nov 19, 2021

In Brief

A Phase 2 clinical trial evaluating Abiraterone acetate, Abiraterone acetate plus degarelix, and 1 other intervention for Prostate Cancer. Completed, enrolled 124 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsJanssen Scientific Affairs, LLC, OHSU Knight Cancer Institute, Rutgers Cancer Institute of New Jersey, Endeavor Health, Duke University, Northwestern University, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, University of North Carolina, Wayne State University, Perlmutter New York University Cancer Center, Weill Medical College of Cornell University, Ferring Pharmaceuticals, GU Research Network, LLC, University of California, Los Angeles

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2012
Enrollment StartDec 18, 2012
Primary CompletionSep 28, 2020
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 13.5 years ago

Interventions

Abiraterone acetatedrug

Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.

Abiraterone acetate plus degarelixdrug

Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.

Degarelixdrug

Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.