Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic… (NCT02020070) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States16 participantsStarted 2013-12-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
Target Population: Cohort A Patients with castration-sensitive oligometastatic prostate cancer who have not received primary local therapy (radiation or surgery), and no more than 5 months of prior androgen deprivation therapy.
* The subject must be age 18 or older, and be willing and able to provide informed consent.
* The subject must have histologically confirmed adenocarcinoma of the prostate with tissue confirmation at selected study site.
* The subject must have newly diagnosed prostate cancer with a metastatic site(s).
* The subject must have a history or presence of ≤ 10 bony metastatic lesions
* Note: bone mets that are not clearly identified on bone imaging, but are biopsy proven are allowed
* History or presence of distant metastatic lymph node(s) (e.g., retroperitoneal or non-regional pelvic lymph nodes) are allowed
* History or presence of regional pelvic lymph nodes (as per AJCC Cancer Staging \[7th edition\]) will be considered a metastatic site if greater than 1.5cm in shortest dimension.
* The subject must have Karnofsky performance status of 80-100.
* Normal organ function with acceptable initial laboratory values:
* WBC ≥ 2000/μL
* ANC ≥ 1000/ μL
* Platelets ≥ 75 x 103/μL
* Creatinine ≤ 2.0 x ULN
* AST/ALT ≤ 2.5 x ULN
* Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
* No active or chronic infection with HIV, Hepatitis B or Hepatitis C (negative screening…