Trial Outcomes & Findings for Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer (NCT NCT03830164)

Last Updated: 2023-10-17

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-17

Participant Flow

Recruitment Details: November 2019 to April of 2021. The recruitment of the participants occurred at the clinic and remotely via telephone calls.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Overall Study STARTED	5	8	1
Overall Study COMPLETED	3	0	1
Overall Study NOT COMPLETED	2	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	1	5
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=5 Participants Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 n=8 Participants Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 n=1 Participants Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The data shows that 0 participants achieved any clinically significant improvement.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 n=1 Participants Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Change in International Index of Erectile Function (IIEF) Scores	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=5 Participants Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 n=8 Participants Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 n=1 Participants Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Number of Participants With Incidence of Adverse Events (AEs) Serious Adverse Event	0 Participants	0 Participants	0 Participants
Number of Participants With Incidence of Adverse Events (AEs) Adverse Event	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: No participants on cohort 2.

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

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 n=1 Participants Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)	1 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 n=5 participants at risk Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 2 n=8 participants at risk Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.	Cohort 3 n=1 participants at risk Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.
Gastrointestinal disorders Stomach Pain	0.00% 0/5 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	12.5% 1/8 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	0.00% 0/1 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	12.5% 1/8 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	0.00% 0/1 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months
Gastrointestinal disorders Diarrhea	0.00% 0/5 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	12.5% 1/8 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	0.00% 0/1 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months
General disorders Blurry vision	0.00% 0/5 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	12.5% 1/8 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months	0.00% 0/1 • at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months

Additional Information

Dr. Chad Tang, Associate Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: (713) 745-7179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place