Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

Inclusion Criteria

• •Patients must have signed an informed-consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
• •Patients must have a history of prostate adenocarcinoma (adenocarcinoma must be the primary histology; secondary components of variant histologies are acceptable) confirmed on biopsy and treated with primary radical prostatectomy (RP) or definitive radiation (RT). Prior salvage RT is acceptable.
• •Patients must have experienced biochemical recurrence (BCR) plus have minimum PSA values noted below:
• •* Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening
• •* Following primary RT: PSA rise to ≥2 ng/mL above the nadir
• •* No evidence of metastases on conventional imaging (CT or MRI plus bone scan)
• •PSA doubling time (PSADT) \<10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa\_doubling\_time)
• •With linear regression model of normal logarithm of PSA and time, based on:
• •At least 3 consecutive PSA values with each value ≥0.2 ng/mL
• •Interval between first and last PSA values is ≥8 weeks but ≤12 months.
• •-Archival tissue is mandatory, either prostatectomy specimen or (in patients who received primary RT) diagnostic core biopsies. Patients must consent to next-generation sequencing performed on this tissue.
• •If diagnostic core biopsies are only available tissue, at least 3 cores must be involved by tumor
• •* Easteron Cooperative Oncology Group (ECOG) performance status 0-1
• •* Age ≥18 years
• •* Adequate organ and marrow function:
• •* System Laboratory Value
• •Hematological
• •White blood cell (WBC) ≥ 2000/µL
• •Absolute Neutrophil Count (ANC) ≥ 1500/μL
• •Platelets (Plt) ≥ 100 x103/μL
• •Hemoglobin (Hgb) \> 9.0 g/dL (with or without transfusion)
• •-Renal
• •Serum Creatinine ≤ 2 x ULN
• •Hepatic
• •Bilirubin1 ≤ 1.5× upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) ≤ 3 × ULN
• •Alanine aminotransferase (ALT) ≤ 3 × ULN
• •* Except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL
• •* Baseline testosterone ≥100 ng/dL
• •* Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no treatment-related toxicity ≥ grade 2.
• •* History of prior malignancy or concurrent separate malignancy is not an exclusion criterion so long as the non-prostate malignancy is stable and does not require any treatment.
• •* Able to understand and sign informed consent and adhere to study procedures.
• •* Male patients whose female partners are of reproductive potential must agree to use a contraception during the trial period