Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in International Index of Erectile Function (IIEF) Scores
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Treatment (atorvastatin, vitamin E, pentoxifylline)
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.
干预措施: Atorvastatin (Drug)
Treatment (atorvastatin, vitamin E, pentoxifylline)
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.
干预措施: Pentoxifylline (Drug)
Treatment (atorvastatin, vitamin E, pentoxifylline)
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.
干预措施: Vitamin E Compound (Dietary Supplement)
结局指标
主要结局
Change in International Index of Erectile Function (IIEF) Scores
时间窗: 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)
次要结局
- Number of Participants With Incidence of Adverse Events (AEs)(Up to 12 months)
- Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)(Up to 12 months)