pilot of osanetant to reduce severity of hot flashes in men with adenocarcinoma of the prostate

Conditions: Prostate Adenocarcinoma

Summary: to evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (adt).


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 prostate cancer (pca) * undergoing active treatment with adt within ≥ 30 days prior to randomization * using either an gonadotropin releasing hormone (gnrh) agonist with a planned duration covering the 8 weeks of the study or are status post bilateral orchiectomy, * have a castrate level of testosterone (≤ 50 ng/dl) at enrollment * have moderate-to-severe hot flashes defined as * seven (7) or more hot flashes per day * total hot flash severity (hfs: total number of hot flashes for 1 week multiplied by the average severity/week) ≥ 100 * adequate organ function, defined as follows: result date * leukocytes \> 1.5k/ul * absolute neutrophil count (anc) \>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 * 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 ≤ 1.5 x uln * women of child-bearing potential and men with partners of childbearing 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 and for 30 days following completion of therapy. exclusion criteria: * concurrent invasive malignancy or invasive malignancy within 2 years except for chronic lymphocytic leukemia/small lymphocytic lymphoma on surveillance, suspected or proven clinical stage 1 (ct1) renal cell carcinoma on active surveillance, or the following malignancies treated with curative intent via surgical resection: carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, low-grade non-muscle-invasive urothelial carcinoma, non-melanoma skin cancer. * simultaneously enrolled in any therapeutic clinical trial * current or anticipating use of other pharmacologic anti-neoplastic (including hormonal), or investigational agents while participating in this study. concurrent treatment with radiotherapy is permitted. * diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * 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. * participants 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.