NL-OMON54856已完成不适用
se of PSMA-PET scanning in selection for active surveillance for low risk prostate cancer - PSMA in Active Surveillance for PRostate cancer Trial PASPoRT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Men >18 years of age
- •- Mentally competent and understanding of benefits and potential burden of the
- •- Written informed consent.
- •- Life expectancy >10 years
- •- Histological confirmed diagnosis adenocarcinoma prostate.
- •- Suitable for radical treatment
- •- Willing to start active surveillance
- •- Underwent systematic biopsies of the prostate, had at least biparametric MRI
- •of the prostate, underwent MRI lesion targeted biopsy in case of visualized
- •lesions (cognitive, software-based, or MRI-in bore fusion of images with
- •transrectal ultrasound)
- •- Currently applied criteria for active surveillance:
- •- PSA <20.0 ng/ml
- •- PSA density <0.2 ng/ml/ml
- •- Clinical and radiological stage T1c-2 Nx-0 Mx-0
- •- Capsular contact <=6 mm on MRI
- •- If maximal Gleason score 3+3=6
- •- in <=33% of systematic biopsy cores (no limit number of positive targeted
- •- no limit number of MRI lesions
- •- no limit diameter MRI lesions
- •- If maximal Gleason score 3+4=7
- •- in maximal 1 systematic biopsy core (no limit number of positive targeted
- •biopsies), other systematic biopsy cores allowed to be positive, as long as
- •total number systematic biopsies <33%
- •- maximal one MRI lesion, ipsilateral to Gleason 3+4=7 biopsy core (indicating
- •that MRI visualized lesion is actually the highest grade lesion)
- •- maximal lesion diameter <15 mm
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Very low risk disease defined as non-palpable, non MRI visualized, 1
- •systematic biopsy only, Gleason 6, PSA less than 10.0 prostate cancer.
- •- Clinical or radiological suggestion of T3 disease.
- •- Gleason score 4+3=7 or higher / less favorable, in any biopsy core.
- •- Gleason score 3+4=7 in more than 1 systematic biopsy core, or in a systematic
- •biopsy core contralateral to the visualized MRI lesions.
- •- More than 1 MRI lesion and detection of Gleason 3+4=7.
- •- Histological cribriform growth pattern
- •- Histological (intra)ductal carcinoma
- •- Concomitant malignancy (except from BCC).
- •- Contra-indications for, or unwillingness to undergo MRI (such as pacemaker,
- •claustrophobia) or PSMA PET-CT.
- •- History of prior diagnosed or treated PCa.
- •- Any unrelated illness (e.g. active infection, inflammation or laboratory
- •abnormalities) that in the judgment of the investigator will significantly
- •affect patient*s clinical status.
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