Clinical trial NCT03830164: Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
Official title: Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Erectile Disorder
Prostate Adenocarcinoma
Erectile Dysfunction, CTCAE
Impotence
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-05
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in International Index of Erectile Function (IIEF) Scores
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Incidence of Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Chad Tang
role: PRINCIPAL_INVESTIGATOR
References: