PSMA in Active Surveillance for PRostate cancer Trial
- Conditions
- Prostate cancer
- Registration Number
- NL-OMON28271
- Lead Sponsor
- St Antonius Hospital Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 141
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Number of and characteristics of PSMA lesions visualized within the prostate gland.<br>- Histology (‘Gleason score’) of targeted biopsies of PSMA visualized lesions, when compared to previous histology.
- Secondary Outcome Measures
Name Time Method - To assess the association between MRI findings in the prostate and local PSMA visualized lesions.<br>- To assess change of management due to PSMA-PET/CT findings and targeted biopsies.<br>- To analyse performance of PSMA lesions targeted prostate biopsies when compared to previously performed (regarding tumor length, core involvement):<br>- Systematic prostate biopsies <br>- MRI lesion targeted biopsies. <br>- Time to deferred active therapy versus historical cohort (hypothesis: Increased acceptance).<br>- Time to deferred active therapy versus historical cohort (hypothesis: Increased adherence).