NCT02778243已完成不适用
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Serum concentrations of sexual steroids and intra-tissue on healthy prostates
研究概览
简要总结
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.
- Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
- Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.
Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.
详细描述
Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :
FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Men aged over 18 years
- •Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
- •Patients affiliated to a social security scheme or benefiting from such a regime.
- •Patients who have given their consent to participate in writing
排除标准
- •Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
- •Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
- •Patient included in another clinical trial inconsistent with the conduct of this research.
- •Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).
结局指标
主要结局
Serum concentrations of sexual steroids and intra-tissue on healthy prostates
时间窗: 30 minutes
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.
次要结局
未报告次要终点
研究者
研究点 (2)
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