se of PSMA-PET scanning in selection for active surveillance for low risk prostate cancer

St Antonius Hospital Research Fund0 个研究点目标入组 141 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Men >18 years of age
•- Mentally competent and understanding of benefits and potential burden of the study.
•- 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 biopsies)
•- 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

•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.

发起方

St Antonius Hospital Research Fund