Prostate cancer
Conditions
Interventions
PSMA PET scan en targeted prostate biopsies
Sponsors
St Antonius Hospital Research Fund
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of and characteristics of PSMA lesions visualized within the prostate gland. - Histology (‘Gleason score’) of targeted biopsies of PSMA visualized lesions, when compared to previous histology. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the association between MRI findings in the prostate and local PSMA visualized lesions. - To assess change of management due to PSMA-PET/CT findings and targeted biopsies. - To analyse performance of PSMA lesions targeted prostate biopsies when compared to previously performed (regarding tumor length, core involvement): - Systematic prostate biopsies - MRI lesion targeted biopsies. - Time to deferred active therapy versus historical cohort (hypothesis: Increased acceptance). - Time to deferred active therapy versus historical cohort (hypothesis: Increased adherence). | — |
Contacts
Public ContactRoderick van den Bergh
St Antonius Ziekenhuis
Outcome results
None listed