pilot of osanetant to reduce testosterone in men with adenocarcinoma of the prostate

Conditions: Prostate Adenocarcinoma

Summary: to evaluate the effect of osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.

primary: to evaluate the effect of osanetant on testosterone levels in men with prostate cancer within 28 days of therapy. secondary: * to evaluate the effect osanetant on pituitary hormones (lh/fsh) and estrogen within 28 days of therapy. * to evaluate the effect of osanetant on psa levels after 28 days (approximately 4 weeks) of therapy.

Eligibility criteria:
inclusion criteria: * ability of participant or legally authorized representative (lar) to understand this study, and participant or lar willingness to sign a written informed consent * males ≥ 18 years * histologic diagnosis of adenocarcinoma of the prostate (pca) * planned radical prostatectomy within the study period * testosterone \>150ng/ml * adequate organ function, defined as follows: result date * leukocytes \>1.5k/ul * absolute neutrophil count \>1.5k/ul * note: patients with established diagnosis of benign neutropenia are eligible to participate with anc between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient. * platelets \>100k/ul * hemoglobin ≥ 9 g/dl * serum creatinine ≤ 1.5 x upper limit of normal (uln) or calculated creatinine clearance ≥ 50 ml/min using the cockcroft-gault equation * total bilirubin ≤ 1.5 x uln or direct bilirubin ≤ 1 x uln * aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x uln unless liver metastases are present, in which case they must be ≤ 5 x uln * men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in child-bearing potential/pregnancy section for the duration of study participation. men of child-bearing potential must not father a child or donate sperm while receiving investigational treatment. following treatment (standard of care prostatectomy) there is no further child-bearing potential. exclusion criteria: * current or recent (within 6 months) use of testosterone/estrogen modulating agents (leuprolide, degarelix, bicalutamide, enzalutamide, apalutamide, darolutamide, abiraterone, systemic ketoconazole, tamoxifen, etc) * current use of cyp3a4 inhibitors * subjects using the following medications within 2 weeks prior to first dosing (or within 5 times the half-life of that medication, whichever is longer) will be excluded from the study: * inhibitors of cyp3a4 (including but not limited to macrolide antibiotics, hiv protease inhibitor, azole antifungal drugs, cyclosporine, calcium channel inhibitor, cimetidine) * inducers of cyp3a4 (including but not limited to rifampicin, carbamazepine, efavirenz, bosentan, modafinil, st. john's wort), medications with narrow therapeutic index that are metabolized cyp3a4 and/or cyp2d6 are not allowed from screening until up to 5 half-lives after last dose of osanetant is administered. * cognitive impairment (defined as the presence of diagnosed dementia) * impaired renal function: cr \>1.8 * medical history of osteoporosis * current systemic corticosteroid, long-term opioid, spironolactone, or eplerenone use * has a known allergic reaction to any excipient contained in the study drug formulation * active grade 3 (per the nci ctcae, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment. * active covid-19 infection * any history of underlying liver disorder, including hepatitis (see below) * any evidence of acute or chronic hepatitis b or c on screening testing * elevation of any or all liver enzymes (alt, ast, total bilirubin) above the upper limit of normal (uln) at baseline testing prior to enrollment * a family history of hepatitis or currently living with a person who has been given a diagnosis of hepatitis * a history of or currently working as a sex worker * a history of or currently using intravenous (iv) drugs * a self-reported history of alcoholic dependency or abuse * a history of or current diagnosis of cardiovascular disease including heart failure, coronary artery disease, uncontrolled hypertension, uncontrolled diabetes; arrhythmias (or history of), or clinically relevant ecg abnormalities at baseline