Status:
COMPLETED
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Male Erectile Disorder
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 ma...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03830164
Start Date
November 20 2019
End Date
November 2 2022
Last Update
October 17 2023
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030