To introduce 68Ga-PSMA-PET/CT scanning in risk stratification of prostate cancer patients assumed to be suitable for active surveillance.
ID
Source
Brief title
PASPoRT
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of PSMA-PET/CT in: 1 - Visualization of lesions in the
prostate. 2 - Histology (*Gleason score*) of targeted biopsies of PSMA
visualized lesions
Secondary outcome
- Visualization of MRI lesions in the prostate on PSMA.
- To assess the association between MRI findings in the prostate and local PSMA
visualized lesions.
- To analyse the performance of PSMA lesions targeted prostate biopsies when
compared to previously performed:
- 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).
- Determining the value of a follow up PSMA scan in detecting disease
progression versus the standard of care.
Background summary
Expectant management (*active surveillance*) for low risk prostate cancer has
become an important part of prostate cancer management. Active surveillance
aims to decrease overtreatment by avoiding or postponing radical therapy of
tumours that are presumed to have an indolent natural course, even when
remaining untreated. Risk stratification of prostate cancer, using clinical
parameters and MRI, in order to decide for active surveillance versus active
therapy, is imperfect.
Study objective
To introduce 68Ga-PSMA-PET/CT scanning in risk stratification of prostate
cancer patients assumed to be suitable for active surveillance.
Study design
Prospective cohort study.
Study burden and risks
In addition to standard care (including: MRI scan, systematic transrectal
biopsies, targeted biopsies of MRI lesions), a PSMA-PET/CT scan will be
performed. The PSMA-PET scan will require: Extra visit and iv drip, small
radiation burden. In the case of PSMA lesions not previously visualized on MRI:
Extra set of transrectal targeted prostate biopsies in outpatient setting (risk
of complications: hematospermia, hematuria, rectal bleeding, infection, fever
(2-3%), pain). Participation in the study may allow for earlier detection of
more aggressive histology.
Westerdijk 18m
Utrecht 3513 EW
NL
Westerdijk 18m
Utrecht 3513 EW
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004667-51-NL |
| CCMO | NL69880.100.20 |
| OMON | NL-OMON28271 |