NCT07278362尚未招募4 期
Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
研究概览
简要总结
The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males aged ≥ 18 years old
- •Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI, and had a second confirmatory biopsy within the last 12 months
- •Males diagnosed with low-risk prostate cancer undergoing active surveillance
- •Two confirmatory testosterone levels <300 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
- •Symptoms of low testosterone (Aging Male's Symptoms Score >27)
- •Able to obtain Testosterone medication through insurance or out-of-pocket
- •Willing and able to provide written informed consent and able to comply with study requirements
排除标准
- •Males <18 years old
- •History of Testosterone Replacement Therapy (TRT) within the past year.
- •Current use of TRT
- •Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
- •PSA >10 ng/mL at baseline
- •Hematocrit > 51% at baseline
- •T3 or T4 disease
- •Uncontrolled cardiovascular disease and sleep apnea
- •History of breast cancer
- •Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation
- •Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket
- •Unable or unwilling to provide informed consent or comply with study requirements
研究组 & 干预措施
Testosterone cypionate
Experimental
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
干预措施: Testosterone cypionate (Drug)
结局指标
主要结局
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
时间窗: 12 months
Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.
次要结局
- Progression-Free Survival (PFS) from Baseline to 5 Years(Baseline to 5 Years)
- Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months(Baseline, 12 Months)
- Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months(Baseline, 12 Months)
- Mean Change in Hematocrit Levels (%) from Baseline to 12 Months(Baseline, 12 Months)
- Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months(Baseline, 12 Months)
- Mean Change in EPIC-26 Scores from Baseline to 12 Months(Baseline, 12 Months)
- Mean Change in SF-12 Scores from Baseline to 12 Months(Baseline, 12 Months)
- Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months(Baseline, 12 Months)
研究者
Bruce R Kava
Professor of Clinical
University of Miami
研究点 (2)
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