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

Primary Purpose

Male Erectile Disorder, Prostate Adenocarcinoma, Erectile Dysfunction, CTCAE

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Atorvastatin

Pentoxifylline

Vitamin E Compound

About this trial

This is an interventional treatment trial for Male Erectile Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (atorvastatin, vitamin E, pentoxifylline)

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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

To report the rate of choosing other ED treatments after PAVE.

Full Information

NCT ID

NCT03830164

First Posted

February 1, 2019

Last Updated

October 10, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03830164

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 20, 2019 (Actual)

Primary Completion Date

November 2, 2022 (Actual)

Study Completion Date

November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (atorvastatin, vitamin E, pentoxifylline)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Other Intervention Name(s)

Oxpentifylline, Pentoxyphylline, PTX, Trental

Intervention Description

Given PO

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin E Compound

Other Intervention Name(s)

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

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Change in International Index of Erectile Function (IIEF) Scores

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of Participants With Incidence of Adverse Events (AEs)

Description

Time Frame

Up to 12 months

Title

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

Description

To report the rate of choosing other ED treatments after PAVE.

Time Frame

Up to 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad Tang

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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