Prostate Adenocarcinoma Clinical Trial
Official title:
Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
Verified date | October 2023 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 2, 2022 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in International Index of Erectile Function (IIEF) Scores | To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE) | 12 months | |
Secondary | Number of Participants With Incidence of Adverse Events (AEs) | The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event. | Up to 12 months | |
Secondary | Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE) | To report the rate of choosing other ED treatments after PAVE. | Up to 12 months |
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