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

NCT03830164 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2018-0785NCI-2019-00235
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Incidence of Adverse Events (AEs)

  Up to 12 months

• Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)

  Up to 12 months

Study Arms (1)

Treatment (atorvastatin, vitamin E, pentoxifylline)

EXPERIMENTAL

Patients receive atorvastatin PO 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 TID for up to 12 months in the absence of disease progression or unacceptable toxicity.

Drug: Atorvastatin; Drug: Pentoxifylline; Dietary Supplement: Vitamin E Compound

Interventions

Atorvastatin DRUG

Given PO

Treatment (atorvastatin, vitamin E, pentoxifylline)

Pentoxifylline DRUG

Given PO

Also known as: Oxpentifylline, Pentoxyphylline, PTX, Trental

Treatment (atorvastatin, vitamin E, pentoxifylline)

Vitamin E Compound DIETARY_SUPPLEMENT

Given PO

Also known as: 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol, E Vitamin, Vitamin E

Treatment (atorvastatin, vitamin E, pentoxifylline)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Atorvastatin; Pentoxifylline; alpha-Tocopherol; Vitamin E

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols; Benzopyrans; Pyrans

Results Point of Contact

• Title: Dr. Chad Tang, Associate Professor, Radiation Oncology Department
• Organization: UT MD Anderson Cancer Center

ctang1@mdanderson.org

(713) 745-7179

Study Officials

• Chad Tang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: November 20, 2019
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: October 17, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-10

Locations

US (1)