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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830164
• Other study ID #: 2018-0785
• Secondary ID: NCI-2019-0023520
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: November 2, 2022

Study information

• Verified date: October 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction, CTCAE
• Impotence
• Male Erectile Disorder
• Prostate Adenocarcinoma

Intervention

Drug:
• Atorvastatin
Given PO
• Pentoxifylline
Given PO

Dietary Supplement:
• Vitamin E Compound
Given PO

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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