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

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ClinicalTrials.gov Identifier: NCT03830164
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Male Erectile Disorder Prostate Adenocarcinoma Erectile Dysfunction, CTCAE Impotence Drug: Atorvastatin Drug: Pentoxifylline Dietary Supplement: Vitamin E Compound Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : September 17, 2022
Estimated Study Completion Date : September 17, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (atorvastatin, vitamin E, pentoxifylline)
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
Given PO

Drug: Pentoxifylline
Given PO
Other Names:
  • Oxpentifylline
  • Pentoxyphylline
  • PTX
  • Trental

Dietary Supplement: Vitamin E Compound
Given PO
Other Names:
  • 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol
  • E Vitamin
  • Vitamin E


Outcome Measures
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Primary Outcome Measures :
  1. Change in International Index of Erectile Function (IIEF) scores [ Time Frame: Baseline up to 12 months ]
    Patients' baseline erectile dysfunction (ED) levels will be reported along with the proportion for patients who improve by at least 1 level according to the IIEF for each time point measured. The proportion will be reported along with a 95% credible interval implementing a non-informative prior of beta (0.33, 0.67). Additionally, the proportion of patients who ever improve by at least 1 level will be reported overall.


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 12 months ]
    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.

  2. Rate of choosing other ED treatments after PAVE [ Time Frame: Up to 12 months ]
    The number of patients who drop out of the study to start an ED prescription medication will be reported.


Other Outcome Measures:
  1. Baseline patient features [ Time Frame: Baseline ]
    Exploratory analyses will be utilized to determine whether baseline patient features can predict response to PAVE or adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830164


Contacts
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Contact: Chad Tang 713-563-2300 ctang1@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Chad Tang    713-563-2300    ctang1@mdanderson.org   
Principal Investigator: Chad Tang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chad Tang M.D. Anderson Cancer Center
More Information
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03830164    
Other Study ID Numbers: 2018-0785
NCI-2019-00235 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0785 ( Other Identifier: M D Anderson Cancer Center )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Pentoxifylline
Atorvastatin
Micronutrients
Physiological Effects of Drugs
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Vasodilator Agents
Free Radical Scavengers