Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
Condition: Male Erectile Disorder; Prostate Adenocarcinoma; Erectile Dysfunction, CTCAE; Impotence
MeSH terms: Erectile Dysfunction
Intervention: Atorvastatin; Pentoxifylline; Vitamin E Compound
Intervention description: Given PO; Given PO; Given PO
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Pentoxifylline; Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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)