Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy - ENFORCE

Canisius Wilhelmina Ziekenhuis0 个研究点目标入组 750 人开始时间: 2020年8月4日最近更新: 2021年1月18日

适应症

试验速览

暂无简介。

•Prescreening eligibility criteria
•1. Signed informed consent form 1 (IC)
•2. Age > 18 years
•3. Histologically confirmed prostate cancer
•4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
•5. Non-metastatic disease (cN0M0)
•6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
•7. Willing to undergo testosterontherapy/placebo by intramuscular injection
•8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.
•Inclusioncriteria:
•8.Signed informed consent form 2 (IC)
•9.Undetectable PSA level at 4-week follow-up
•10. pT2-pT3a on specimen after RP
•11. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.
•12. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.
•13. No general contra-indications for testosterone therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

•Prescreening exclusion criteria:
•1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed)
•2. Previous use of testosterontherapy for any reason
•3. History of male breast cancer
•4. History of liver tumor
•5. Uncontrolled hypertension
•6. Allergy for components in the testosterone therapy agent or placebo
•7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)
•8. metastases (cN1/M1)

发起方

Canisius Wilhelmina Ziekenhuis