ISRCTN50041002已完成不适用
4Kscore as a predictor of tumor reclassification.
Servicio Urología. Instituto Valenciano de Oncología0 个研究点目标入组 300 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Male
入选标准
- •1. PSA = 10 ng / mL; if prostate volume> 60 cc in transrectal, ultrasound included with PSA>10 ng / ml if PSAD <0.20
- •2. Local Stadium DRE; cT1c -cT2a
- •3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
- •4. Adenocarcinoma Prostate Gleason = 6 (3 + 3) with local and central pathology review
- •5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of
- •6. <80 years and greater expectancy to 10 years life (Charlson score)
- •7. Patients able to understand VA and sign the informed consent
- •8. Possibility for the Hospital Project and associated patient acceptance at inclusion to performance the test of 4Kscore followed by a biopsy confirmation at 6 months diagnostic. This transrectal ultrasound-guided biopsy may be making 18 cylinders or ultrasound-guided transperineal brachytherapy making from 24 to 32 cylinders according with prostate volume. Both possibilities allow extra biopies to confirm suspected areas by ultrasound or RMNmp 1.5T (which is optional)
排除标准
- •1. Patient not be able to accept repeat biopsies
- •2. Patient who does not want to sign the Informed Consent
- •3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
- •4. If the central pathology review of diagnostic biopsy is estimated not met
- •inclusion criteria marking the protocol
- •5. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglándulas)
- •6. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avodart®) and finasteride (Proscar®) during the previous six months
- •7. Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy
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