NL-OMON52940招募中3 期
Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE) - ENFORCE
Canisius Wilhelmina Ziekenhuis0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent form 1 (IC)
- •2. Age > 18 years
- •3. Histologically confirmed prostate cancer
- •4. Scheduled for RP as primary treatment with at least one-side nervesparing.
- •5. Non-metastatic disease (cN0M0)
- •6. Willing to provide blood samples to determine testosterone level
- •7. Signed informed consent form 2 (ICF)
- •8. Undetectable PSA level at 4-week follow-up
- •9. Willing to use testosterone gel or placebo gel
- •10. a minimal score of 40 points for the EPIC-26 sexual domain.
排除标准
- •1. Any previous treatment for prostate cancer, for example but not limited to:
- •anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is
- •2. Previous use of TRT 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. pT3b or pT4
- •9. Positive surgical margin (PSM) and ISUP 4 or 5 (ISUP 1 to 3 with PSM and
- •ISUP 4 or 5 without PSM can be included).
- •10. Metastatic lymph nodes if a PLND has been done
- •11. BMI > 30
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