Trials / Completed
CompletedNCT03830164
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atorvastatin | Given PO |
| DRUG | Pentoxifylline | Given PO |
| DIETARY_SUPPLEMENT | Vitamin E Compound | Given PO |
Timeline
- Start date
- 2019-11-20
- Primary completion
- 2022-11-02
- Completion
- 2022-11-02
- First posted
- 2019-02-05
- Last updated
- 2023-10-17
- Results posted
- 2023-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03830164. Inclusion in this directory is not an endorsement.