NCT00553878已完成2 期
Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer
Canadian Urology Research Consortium1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
研究概览
简要总结
Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.
详细描述
The study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05 mg on the length of the off treatment interval in men receiving intermittent androgen therapy for localized prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •Age_>45and<_80
- •Histological confirmed adenocarcinoma of prostate
- •Has received external beam radiation,brachytherapy or radical prostatectomy for the treatment of prostate ca
- •Candidate for intermittent androgen ablation
- •Minimum of 3 PSA values above nadir taken at least 1 month apart
- •Serum testosterone >_250ng/dl,ECOG 0 or 1
- •Negative bone scan within 12 months of visit 1
- •Able to swallow and retain oral medication
排除标准
- •Previous treatment with chemotherapy
- •Hormonal therapy with in last year
- •Glucocorticoid with in last 3 months
- •LHRH analogues with in previous year
- •Ketoconazole
- •Non Steroidal anti-androgens with in previous year
- •Concurrent or previous use of Finasteride Dutasteride 5a reductase inhibitor anabolic steroids
- •Over the counter or herbal prep such as saw palmetto selenium or vitamin E within last year
- •May not be receiving any other investigational drug with in last 30 days
- •Evidence of distant metastases
- •Has received adjuvant or neoadjuvant ablation in past 12 months
- •Unstable serious co-existing medical condition
- •Abnormal liver and kidney functions
- •Previous malignancy not including curative treated basal cell carcinoma of skin with in 5 years and bladder cancer with in past 2 years
- •Known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to dutasteride
- •Known hypersensitivity to bicalutamide.
研究组 & 干预措施
dutasteride
Placebo Comparator
干预措施: Dutasteride (Drug)
结局指标
主要结局
To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
时间窗: 2 Years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Firmagon (Degarelix) Intermittent TherapyProstate Cancer RecurrentNCT01512472Canadian Urology Research Consortium144
进行中（未招募）
3 期
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPCMetastatic Castrate-sensitive Prostate CancerNCT05884398Janssen Research & Development, LLC420
Unknown
4 期
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate CancerPatients With T1-4 Advanced Prostate CancerNCT00293670Tampere University573
已完成
2 期
Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate CancerProstate AdenocarcinomaStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage III Prostate CancerNCT00589472National Cancer Institute (NCI)19
招募中
3 期
Clinical trial of androgen deprivation therapy combined with salvage radiotherapy when treating prostate cancer that has suffered recurrence after surgeryProstate Cancer2024-517666-41-00Instituto De Investigacion En Oncología Radioterapica FEOR534