Male Erectile DisorderPhase 2NCT03830164

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

A Phase 2 study testing Atorvastatin, Pentoxifylline and Vitamin E Compound in people with Male Erectile Disorder and Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Male Erectile Disorder, Prostate Adenocarcinoma, Erectile Dysfunction, CTCAE
What is being tested?: Atorvastatin, Pentoxifylline and Vitamin E Compound
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2019to 2 Nov 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction

Read the detailed description

PRIMARY OBJECTIVE:

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:

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.

Conditions: Male Erectile Disorder, Prostate Adenocarcinoma, Erectile Dysfunction, CTCAE, Impotence
Being tested: Atorvastatin, Pentoxifylline, Vitamin E Compound
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtorvastatinDrug
Given PO
PentoxifyllineDrug
Also called Oxpentifylline, Pentoxyphylline, PTX, Trental
Given PO
Vitamin E CompoundDietary supplement
Also called 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol, E Vitamin, Vitamin E
Given PO

Study groups in NCT03830164
Study group	Role	What they receive
Treatment (atorvastatin, vitamin E, pentoxifylline)	Experimental	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. Receives: Drug: Atorvastatin; Drug: Pentoxifylline; Dietary Supplement: Vitamin E Compound

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 12 months

Secondary outcomes (2)

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.
Measured: Up to 12 months
Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)
To report the rate of choosing other ED treatments after PAVE.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20192 Nov 2022

First posted5 Feb 2019
Study start20 Nov 2019
Primary completion2 Nov 2022
Study completion2 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Male Erectile DisorderStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03830164
Sponsor's protocol ID: 2018-0785
Other IDs: NCI-2019-00235, 2018-0785
Status last verified: Oct 2023
First submitted: 1 Feb 2019
Last updated: 17 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
ClinicalTrials.gov ID: NCT03830164
Acronym / sponsor ID: 2018-0785
Conditions: Male Erectile Disorder, Prostate Adenocarcinoma, Erectile Dysfunction, CTCAE, Impotence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 20 Nov 2019 (actual)
Primary completion: 2 Nov 2022 (actual)
Study completion: 2 Nov 2022 (actual)
First posted: 5 Feb 2019 (actual)
Results: Posted 3 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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

OUTLINE:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (atorvastatin, vitamin E, pentoxifylline)	Experimental	Drug: Atorvastatin, Drug: Pentoxifylline, Dietary Supplement: Vitamin E CompoundPatients 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtorvastatinGiven PO	Drug	Treatment (atorvastatin, vitamin E, pentoxifylline)
PentoxifyllineAlso: Oxpentifylline, Pentoxyphylline, PTX, TrentalGiven PO	Drug	Treatment (atorvastatin, vitamin E, pentoxifylline)
Vitamin E CompoundAlso: 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol, E Vitamin, Vitamin EGiven PO	Dietary supplement	Treatment (atorvastatin, vitamin E, pentoxifylline)

Primary outcome

Change in International Index of Erectile Function (IIEF) Scores
Time frame: 12 months
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)

2 secondary outcomes

Number of Participants With Incidence of Adverse Events (AEs)
Time frame: Up to 12 months
Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 3 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	5	3
Cohort 2	8	0
Cohort 3	1	1

Primary outcome: Change in International Index of Erectile Function (IIEF) Scores

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Cohort 1 n = 3	Cohort 2 n = 0	Cohort 3 n = 1
Value	0	0	0

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Cohort 2	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Cohort 3	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Male Erectile Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chad Tang principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Index of Erectile Function (IIEF) Scores (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03830164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.