Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer

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 astestosterone > 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 upperlimits of normal (ULN)
• Creatinine kinase < 5 times ULN
• Normal renal function is defined as creatinine clearance >= 30 ml/min via theCockcroft 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) proteaseinhibitors, 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 physicianwould 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 wouldmake PAVE unsafe
• No prior radical prostatectomy, cystoprostatectomy, abdominoperineal resection orretroperitoneal lymph node dissection
• Not currently taking a 5PDE inhibitor nor have used one within 30 days of enrolling inthe 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 thanASA
• No concurrent drugs with anti-platelet therapy properties (e.g., P2Y12 inhibitors,non-steroidal anti-inflammatory agents, selective serotonin reuptake inhibitors) otherthan low dose ASA (81 mg/d)
• Not currently taking high dose statin therapy, defined as rosuvastatin > 10 mg/d oratorvastatin > 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 makePAVE unsafe
• No concurrent use of CYP1A2 inhibitors (e.g., ciprofloxacin), ketorolac, or vitamin Kantagonists (e.g. warfarin)