A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
研究概览
简要总结
The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
详细描述
STUDY SUMMARY
TITLE: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) in the Management of Symptomatic Prostatic Enlargement/Hypertrophy OBJECTIVE: To determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H)
EXPERIMENTAL PLAN:
PATIENT SELECTION: Inclusion Criteria
- Patients who demonstrate clinical evidence of failure after treatment with Finasteride for 12 or more months. Failure includes one or more of the following: (i) AUA SS > 10; (ii) Q-max < 10 cc/sec; (iii) Post void residual volume (PVR) >200cc.
- Patients who remain subjectively symptomatic of LUTS secondary to BPH after treatment with Finasteride for at least six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS> 10;Q-max > 5cc/sec and <10c/sec (total voided volume of at least 125cc); post void volumes > 200cc)
- •Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement
- •Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)
- •Willingness and ability to give written informed consent and comply with study instructions and procedures.
排除标准
- •Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
- •Total serum corrected PSA of greater than 15 ng/ml
- •History or clinical evidence of prostate cancer
- •History of acute urinary retention in three months prior.
研究组 & 干预措施
study drug
Open label, single arm
干预措施: Dutasteride (Drug)
结局指标
主要结局
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
时间窗: 12 months
次要结局
- To assess safety and tolerability of Dutasteride(12 months)
研究者
Unyime O. Nseyo, MD
PHYSICIAN
North Florida/South Georgia Veterans Health System