A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 11
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
详细描述
The primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression.
The secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and PSA levels; to explore AR levels in circulating tumor cells as a marker of treatment benefit.
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
- Double (Participant, Investigator)
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
- •Prostate cancer
- •Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
- •Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
- •Patient must have had a previous trial of anti-androgen therapy
- •Patient must have a rising PSA
- •No evidence of distant metastatic disease
- •ECOG performance status < 2
- •Age >18 years
- •Patients must have normal hepatic function
排除标准
- •Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
- •Patients may not be receiving any other investigational agents
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients receiving renal dialysis
- •Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
- •Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy
研究组 & 干预措施
A
Twenty subjects will receive testosterone gel
干预措施: AndroGel (Drug)
B
Twenty subjects will receive the placebo
干预措施: placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 5 years
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
次要结局
- To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.(every 8 weeks)