Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03830164|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction, CTCAE Impotence Prostate Adenocarcinoma||Drug: Atorvastatin Drug: Pentoxifylline Dietary Supplement: Vitamin E Compound||Phase 2|
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).
I. To report the safety profile of PAVE. II. To report the rate of choosing other ED treatments after PAVE.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pentoxifylline, Atorvastatin and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||September 17, 2022|
|Estimated Study Completion Date :||September 17, 2022|
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.
Dietary Supplement: Vitamin E Compound
- 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.
- 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.
- 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.
- 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.
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
|Contact: Mitchell Anscherfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mitchell S. Anscher 713-563-2300|
|Principal Investigator: Mitchell S. Anscher|
|Principal Investigator:||Mitchell Anscher||M.D. Anderson Cancer Center|