Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
研究概览
简要总结
This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer.
Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function.
Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.
详细描述
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cancer.
Recent laboratory findings in rat models and on human urogenital tissues suggest that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively in a prospective, randomized study. Erythropoietin has been used in many men undergoing open radical prostatectomy in the past according to FDA indications for preparation for noncardiac, nonvascular surgery with a high risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer undergoing radical prostatectomy.
The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The dose is given by subcutaneous injection. The study will also require the completion of questionnaires which will be completed online every three months until study completion (at 3, 6, 9, and 12 months) to assess outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient eligibility consists of men 40 to 65 years of age
- •Localized prostate cancer
- •clinical stage T2a or lower
- •Gleason grade of 3+4 or 3+3
- •prostate specific antigen (PSA) < 10
- •Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
- •International Index of Erectile Function-5 (IIEF-5) score of 22-
- •The patient has a sexual partner, of at least 6 months.
- •The patient's pre-surgical hematocrit is ≤
- •The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.
排除标准
- •The patient has known penile deformity or a history of Peyronie's disease.
- •The patient has planned pre or post operative androgen therapy.
- •The patient has planned pre or post operative radiation therapy.
- •The patient is on anticoagulation therapy.
- •The patient has a history of sickle cell anemia.
- •The patient has a history of high or low blood pressure that is not controlled.
- •The patient is taking medications called "nitrates"
- •The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
- •The patient has a history of history of drug or alcohol abuse.
- •The patient currently smokes or has a 20 pack/year history of cigarette smoking.
- •The patient has a history of acute or chronic depression
- •The patient has a history liver problems, or kidney problems.
- •The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
- •The patient has a history of spinal trauma or surgery to the brain or spinal cord.
- •The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
- •Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.
研究组 & 干预措施
Erythropoietin (EPO)
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
干预措施: Erythropoietin (EPO) (Drug)
Placebo
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
时间窗: At 6 months post-surgery
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
次要结局
- Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain(At 12 months post-surgery)
- Patient Score on the Overall IIEF Questionnaire(At 12 months post-surgery)
- Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)(At 12 months post-surgery)
- Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain(At 12 months post-surgery)
- Number of Participants Requiring Transfusion During Hospitalization(During hospital stay, up to 1 week)
- Patient Score on the Quality of Erection Questionnaire (QEQ)(At 12 months post-surgery)
- Hemoglobin Level at 2 Weeks After Surgery(2 weeks after surgery)