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

Completed

Conditions: prostaatkanker
10038597

Registration Number: NL-OMON54856

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 141

Inclusion 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

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
<p>Diagnostic accuracy of PSMA-PET/CT in: 1 - Visualization of lesions in the<br /><br>prostate. 2 - Histology (Gleason score) of targeted biopsies of PSMA<br /><br>visualized lesions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Visualization of MRI lesions in the prostate on PSMA.<br /><br>- To assess the association between MRI findings in the prostate and local PSMA<br /><br>visualized lesions.<br /><br>- To analyse the performance of PSMA lesions targeted prostate biopsies when<br /><br>compared to previously performed:<br /><br>- Systematic prostate biopsies.<br /><br>- MRI lesion targeted biopsies.<br /><br>- Time to deferred active therapy versus historical cohort (hypothesis:<br /><br>Increased acceptance)..<br /><br>- Time to deferred active therapy versus historical cohort (hypothesis:<br /><br>Increased adherence).<br /><br>- Determining the value of a follow up PSMA scan in detecting disease<br /><br>progression versus the standard of care. </p><br>