pentoxifylline, atorvastatin, and vitamin e in treating patients with erectile dysfunction after radiation therapy for prostate cancer

Conditions: Male Erectile Disorder; Prostate Adenocarcinoma; Erectile Dysfunction, CTCAE; Impotence

Summary: 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.

primary objective: i. to estimate the proportion of patients who achieve a clinically significant improvement in erectile dysfunction (ed) when treated with a combination of atorvastatin or patient's currently prescribed statin, vitamin e, and pentoxifylline (pave). secondary objectives: i. to report the safety profile of pave. ii. to report the rate of choosing other ed treatments after pave. outline: patients receive atorvastatin orally (po) once daily (qd) for up to 6 weeks in the absence of disease progression or unacceptable toxicity. beginning week 7, patients receive atorvastatin po qd, vitamin e po qd, and pentoxifylline po thrice daily (tid) for up to 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
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)