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

• Status: Recruiting
• Trial end date: 2022-09-17
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: alpha-Tocopherol; Atorvastatin; Atorvastatin Calcium; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

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)