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About
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.
Enrollment
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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:
No active or chronic infection with HIV, Hepatitis B or Hepatitis C (negative screening tests required).
The subject must be deemed medically fit for radical prostatectomy by the attending urologic surgeon at the selected study site.
Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last dose of ipilimumab] in such a manner that the risk of pregnancy is minimized.
Exclusion criteria
Inclusion Criteria:
Target Population: Cohort B
The subject must be age 18 or older, and be willing and able to provide informed consent.
Histologically confirmed prostate cancer 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.
PSA doubling time of ≤ 12 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm)
No active or chronic infection with HIV, Hepatitis B or Hepatitis C (negative screening tests required).
Prior radiotherapy to the prostate (adjuvant or salvage radiotherapy) is allowed
Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last dose of ipilimumab] in such a manner that the risk of pregnancy is minimized.
Exclusion Criteria:
Target Population: Cohort B
Patients that meet any of the criteria listed below will not be eligible for Cohort B entry:
Primary purpose
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16 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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