Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction

2018-0785

This phase II trial studies how well pentoxifylline, atorvastatin, and vitamin E (PAVE) work in treating patients with erectile dysfunction after radiation therapy for prostate cancer. Atorvastatin may reduce high cholesterol. Pentoxifylline and vitamin E may enhance blood flow. Giving PAVE may work better in treating prostate cancer patients with post-radiation therapy erectile dysfunction.

2019-11-20

2022-11-02

2022-11-02

Completed

Early phase I

14

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate * Previous radiation therapy (any form) with curative intent for prostate cancer * Erectile dysfunction, as determined by an International Index of Erectile Function (IIEF)-5 score of \< 22 * Normal testosterone (including men on testosterone replacement), defined as testosterone \> 150 ng/dl at the time of screening * Karnofsky Performance Status (KPS) \>= 70, or Eastern Cooperative Oncology Group (ECOG) 0-2 * Patients may be taking an HMG-coA-reductase inhibitor * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 X upper limits of normal (ULN) * Creatinine kinase \< 5 times ULN * Normal renal function is defined as creatinine clearance \>= 30 ml/min via the Cockcroft Gault formula Exclusion Criteria: * No androgen deprivation therapy within the past 12 months * No contraindication to an HMG-coA-reductase inhibitor, vitamin E or pentoxifylline * Not currently taking cyclosporine, the human immunodeficiency virus (HIV) protease inhibitors, hepatitis C protease inhibitors, gemfibrozil, other fibrates, clarithromycin, itraconazole or strong inhibitors of CYP3A4 * No recent cerebral or retinal hemorrhage that in the opinion of the treating physician would make PAVE unsafe (within 6 months) * No current chemotherapy during study participation * No active liver or muscle disease that in the opinion of the treating physician would make PAVE unsafe * No prior radical prostatectomy, cystoprostatectomy, abdominoperineal resection or retroperitoneal lymph node dissection * Not currently taking a 5PDE inhibitor nor have used one within 30 days of enrolling in the study * No recent deep venous thrombosis, myocardial infarction or pulmonary embolism (within 6 months) requiring continued anticoagulation other than aspirin (acetylsalicylic acid \[ASA\]) * No cardiac arrhythmias or artificial heart valves requiring anticoagulation other than ASA * No concurrent drugs with anti-platelet therapy properties (e.g., P2Y12 inhibitors, non-steroidal anti-inflammatory agents, selective serotonin reuptake inhibitors) other than low dose ASA (81 mg/d) * Not currently taking high dose statin therapy, defined as rosuvastatin \> 10 mg/d or atorvastatin \> 40 mg/d * Not currently taking theophylline * No history of active peptic ulcer disease in the past 6 months * No history of intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline and theobromine that in the opinion of the treating physician would make PAVE unsafe * No concurrent use of CYP1A2 inhibitors (e.g., ciprofloxacin), ketorolac, or vitamin K antagonists (e.g. warfarin)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

2023-10-17