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

PRIMARY OBJECTIVES:

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.

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) score of < 22

- Normal testosterone (including men on testosterone replacement)

- Karnofsky Performance Status (KPS) >= 70

- Patients may be taking an HMG-coA-reductase inhibitor

- Normal renal function

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 (within 6 months)

- No current chemotherapy

- No active liver or muscle disease, transaminases < 3 times normal

- Creatine kinase (CK) < 5 times normal

- 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 anti-platelet therapy other than ASA

- Not currently taking high dose statin therapy, defined as rosuvastatin > 10mg/d or
atorvastatin > 40mg/d

- Not currently taking theophylline

- No history of peptic ulcer disease in the past 6 months