Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy
The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with degarelix before surgery to remove the prostate, followed by more degarelix and ipilimumab after the surgery, will have on prostate cancer.
The goal of this trial is to assess the safety and efficacy of a multimodality approach combining hormones and immunotherapy in prostate cancer populations that are considered incurable and standardly treated with hormones alone, and represent clinical states prior to development of castration-resistant disease. There are 2 cohorts. The first will use ipilimumab and degarelix prior to and following radical prostatectomy in men with newly diagnosed, oligometastatic, castration-sensitive disease. The second cohort will include men who have already received definitive local therapy with radical prostatectomy but have since experienced biochemical and/or metastatic recurrence.
Metastatic Castration Sensitive Prostate Cancer
Procedure: Radical Prostatectomy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy|
- undetectable PSA [ Time Frame: at 12 and 20 months ] [ Designated as safety issue: No ]An undetectable PSA at 12 and 20 months (weeks 52 and 84, respectively) from the start of treatment among patients with non-castrate (> 150 ng/ml) levels of testosterone. An undetectable PSA is defined as PSA ≤0.05 ng/mL.
- progression-free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression-free survival (PFS) is a composite endpoint defined as disease progression in bone or soft-tissue, symptoms, or death measured from study entry. Progression in soft tissue will be measured by modified RECIST per PCWG2..
- overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall survival is defined as death from any cause measured from study entry.
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (http://ctep.cancer.gov). Safety assessments will be based on medical review of AE reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab & Degarelix With Radical Prostatectomy
Week 1: Degarelix SQ injection (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose) and Ipilimumab at 3 mg/kg intravenously (IV). Surgery Radical prostatectomy (RP)will be performed during week 3 ± 1 week or after recovery to grade ≤ 1 adverse events experienced during the induction period related to treatment. Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose)
Week 11, 14, 17 or after sufficient wound healing and recovery post RP:
Ipilimumab 3 mg/kg IV Follow-up Twelve week intervals until Week 87.
|Drug: Degarelix Drug: Ipilimumab Procedure: Radical Prostatectomy|
Experimental: Ipilimumab & Degarelix With Prior With Radical Prostatectomy
Week 1: Degarelix 240 mg SQ injection and Ipilimumab at 3 mg/kg intravenously (IV) Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ Week 4,7,10: Ipilimumab 3mg/kg IV Follow-up Twelve week intervals until Week 81, with MD visits at weeks 52 and 84 (12 and 20 months).
|Drug: Degarelix Drug: Ipilimumab|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020070
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Karen Autio, MD||Memorial Sloan Kettering Cancer Center|