Clinical trial · Interventional
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
NCT03830164CI-TRIAL-00070527completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction, CTCAE | — | UNRESOLVED | — |
| Impotence | — | UNRESOLVED | — |
| Male Erectile Disorder | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Pentoxifylline | Drug | — | UNRESOLVED |
| Vitamin E Compound | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (atorvastatin, vitamin E, pentoxifylline)
- description
- 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.
- interventionNames
- Drug: Atorvastatin
- Drug: Pentoxifylline
- Dietary Supplement: Vitamin E Compound
Primary outcomes (1)
- measure
- Change in International Index of Erectile Function (IIEF) Scores
- timeFrame
- 12 months
- description
- 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)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.