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

Status:Not yet recruiting
Conditions:Erectile Dysfunction
Therapuetic Areas:Nephrology / Urology
Age Range:18 - Any
Start Date:May 31, 2019
End Date:September 17, 2022
Contact:Mitchell Anscher

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Pentoxifylline, Atorvastatin and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction

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.


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).


I. To report the safety profile of PAVE. II. To report the rate of choosing other ED
treatments after PAVE.


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

- No cardiac arrhythmias or artificial heart valves requiring anticoagulation other than

- 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
We found this trial at
Houston, Texas 77030
Principal Investigator: Mitchell S. Anscher
Phone: 713-563-2300
Houston, TX
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