Phase 2
Completed N=124
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
Source: ClinicalTrials.gov NCT01751451 ↗Enrolled (actual)
124
Serious AEs
8.9%
Results posted
Nov 2021
Primary outcomePrimary: Progression-free Survival (PFS) — 5.1; 17.1; 11.9 percentage change of PSA
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
5.1; 17.1; 11.9 | — |
| PRIMARY Soft Tissue Complete Response |
— | — |
| SECONDARY PSA Response Rate |
— | — |
| SECONDARY Overall Quality of Life |
— | — |
| SECONDARY Non-hematologic Adverse Events |
— | — |
| SECONDARY Testosterone and Luteinizing Hormone (LH) Recovery Rates |
— | — |
| SECONDARY Correlative Tissue Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Male aged 18 years and above
- Patients must have undergone local treatment via radical prostatectomy
- Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.
- Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible
- Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:
- Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND
- PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR
- Rising PSA as defined above AND
- Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes 2 treatment-related toxicity from prior therapy
- Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone or degarelix
- Administration of an investigational therapeutic within 30 days of Cycle 1, Day1
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
Data sourced from ClinicalTrials.gov (NCT01751451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.