A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
研究概览
简要总结
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
详细描述
Benign Prostatic Hyperplasia (BPH) is the most common neoplastic condition afflicting middle-aged and elderly men. BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms (LUTS). These symptoms include: frequency, urgency, weak urinary stream, difficulty starting or stopping to urinate and feeling the need to urinate even after just finishing urinating.
One of the minimally invasive treatments for BPH is a Laser TURP. The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago, Illinois.
Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors (5ARI). Dutasteride is a 5ARI that has been approved by the U.S. Food and drug Administration (FDA) for the treatment of BPH.
Each participant in this study will be randomized into ONE of the treatment groups below:
- Laser TURP combined with Dutasteride
- Laser TURP combined with placebo.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient is a male at least 50 years of age.
- •The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml.
- •Prostate volume must be greater than 30 grams
- •The AUA-SI is greater than or equal to
- •Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP
- •Patient must be able to complete the study requirements prior to the scheduled laser TURP.
- •The patient has signed the informed consent prior to the performance of any study procedures.
排除标准
- •The patient has had any prior surgical intervention for BPH.
- •The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol.
- •The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride.
- •The patient has taken an alpha-1 blocker within 1 month of randomization.
- •The patient has taken finasteride or dutasteride within 3 months of randomization.
- •The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit.
- •The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids.
- •The patient has an inability to urinate.
- •The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg/dl or AST greater than 1.5 times the upper limit of normal).
- •The patient has a PSA level greater than 10 ug/ml (Hybritech).
- •The patient requires the daily use of a pad or device for incontinence.
- •The patient has had an episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
- •The patient has a penile prosthesis or artificial urinary sphincter.
- •The patient has a history or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, prior surgery for BPH, or bladder neck obstruction.
- •The patient has an active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within two weeks prior to the first screening visit.
- •The patient has known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
- •The patient has had documented bacterial prostatitis within the past year.
- •The patient has had two documented urinary tract infections of any type in the past year. A urinary tract infection is defined as >100,000 colonies per ml urine from midstream clean catch or catheterized specimen.
- •The patient has a severe bleeding disorder that makes laser TURP impossible.
- •The patient must be able to stop any anticoagulant, NSAID or anti-platelet for 7 days prior to the laser TURP.
- •The patient has had cancer that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A patient is considered cured if there has been no evidence of cancer within five years of randomization.
- •The patient has a diagnosis of a thought disorder (i.e., schizophrenia, bipolar disorder)
- •The patient has any serious medical condition likely to impede successful completion of the study.
- •The patient has a defibrillator that cannot be deactivated during laser TURP treatment.
- •A bladder neck to verumontanum distance which is less than 30mm in length as measured by flexible cystoscopy and a total prostate volume <25 ml or >110 ml as measured by prostate volume ellipsoid formula during TRUS.
研究组 & 干预措施
Laser TURP with dutasteride
Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
干预措施: Dutasteride (Avodart) (Drug)
Laser TURP with placebo
Prior to and after standard treatment with laser TURP, placebo is applied to each patient
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
时间窗: one year
AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
次要结局
未报告次要终点
研究者
Kevin McVary
Professor
Northwestern University