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.
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
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
Show all 9Show fewer
- 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
Show all 16Show fewer
- 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.
About this study
Official title: Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chad Tang, Principal investigator, M.D. Anderson Cancer Center
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