Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Prostate-Specific Antigen (PSA) value
研究概览
简要总结
The proposed prospective study aims to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. If PSA levels are found to rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by upward correction of the PSA level. A 'correction factor' may be proposed for the interpretation of PSA levels in obese men, toward the clinical decision regarding indication for prostate biopsy.
详细描述
The main objective of this study is to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. Secondary outcome measures that will be followed include the affect of obesity and weight loss on testosterone, estradiol and leptin. In as much as these might also affect PSA, we will be measuring these values as well. Also, we do not know the effects of lap-band induced weight loss on clinical outcome measures of sexual, bowel and urinary function. Thus we will aim to investigate these parameters as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •obese men undergoing lap-band surgery
排除标准
- •prior diagnosis of prostate cancer
- •prior prostate surgery
- •use of 5-alpha reductase inhibitors
- •history of prostatitis
- •recurrent Urinary Tract Infection (UTI).
结局指标
主要结局
Prostate-Specific Antigen (PSA) value
时间窗: 18 months
The PSA serum test measures the level of PSA in a man's blood. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
次要结局
- Effect of Lapband-induced weight loss on quality of life(18 months)
- Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance(18 months)
- Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms(18 months)
- Effect of Lapband-induced weight loss on sexual function(18 months)