Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05078359 |
| Other study ID # |
OspedaliRFUrology01 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Ospedali Riuniti di Foggia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The PROMOD study is an international multicenter retrospective Project. The aim is to create
a comprehensive database that will include multiple heterogeneous cohorts in order to explore
inter-center differences in the accuracy of Magnetic Resonance Imaging (MRI) in the diagnosis
of prostate cancer and to define optimal strategies for the selection of men at risk of
clinically significant prostate cancer who might benefit from biopsies.
Description:
Background:
In the recent years Magnetic Resonance Imaging (MRI) of the prostate and targeted biopsy have
been shown to substantially improve detection of International Society of Urological
Pathology (ISUP) prostate cancer (PCa) Gleason Grade Group (GG) ≥ 2, clinically significant
prostate cancer (csPCa). In fact, 2020 European Association of Urology (EAU) guidelines
recommend performing MRI before prostate biopsy in men with prior negative prostate biopsy as
well as in biopsy naive men with a clinical suspicion of PCa. If MRI is positive, a
combination of targeted and systematic biopsy should be performed. If MRI is negative, biopsy
could be omitted based on the clinical suspicion of PCa and a shared decision-making with the
patient. Such approach binds the decision to perform biopsy to the clinical suspicion of PCa
to be determined using MRI, risk calculators, and biomarkers. While several risk calculators
and biomarkers have been developed and are currently under evaluation, the 'MRI pathway' is
supported by level 1 evidence but seems to be limited by the low to moderate inter-reader and
inter-center reproducibility and the low specificity/positive predictive value.
Additionally, several techniques for target prostate biopsies have been described but recent
studies found no significant differences among various methods of MRI targeted biopsy for
csPCa detection.
The aim of this international multicenter project is to create a comprehensive database
including multiple heterogeneous cohorts in order to explore inter-center differences in the
accuracy of MRI, and define optimal strategies for selection of men who might benefit from
biopsies.
Objectives:
1. To investigate variables (such as lesion size, lesion location, number of biopsy cores
per lesion) affecting the Positive predictive value (PPV) of prostate MRI on lesion
level and patient level.
2. To explore inter-center differences in PPV of prostate MRI and possible reasons for such
differences on lesion level and patient level
3. To evaluated combined use of MRI with prostate-specific antigen (PSA) and other clinical
variables (such as age, race, history of prior negative prostate biopsy, use of
5-alpha-reductase inhibitor, family history of PCa/csPCa) in A. men with a clinical
suspicion of PCa, B. men with diagnosed prostate cancer on active surveillance
4. To assess if there is an optimal cut-off of MRI suspicious scores and PSA density (PSAd)
in each individual institution.
5) to assess the impact of patient selection on biopsy rate and number of men who could
safely avoid biopsy despite MRI suspicious findings in per center and pooled data analyses
Outcome:
Histological evidence of Clinically significant Prostate Cancer (csPCa), defined as Gleason
score 3+4 or higher.
Inclusion criteria:
- Patients who received prostate biopsy with a pre-biopsy MRI.
- Additional inclusion criteria will be project-specific.
Methods:
Deidentified data from each cohort will be collected in a RedCap HIPPA compliant Database.
Each center is responsible for the deidentification of the shared spreadsheet. The data
handling center will be the University of Foggia (Foggia, Italy) and datasets will not be
imported until data transfer agreements are complete between the institution sending data and
the data handling center.
Data analysis Retrospective analyses of multiple prospective single- and multi-institutional
clinical trials and cohort studies. The analysis will be performed on per center level as
well using pooled dataset and will include comparisons of MRI and clinical, blood variables
in men who underwent A. target biopsy only, B. targeted and systematic biopsy, C. systematic
biopsy only. Decision curve analysis will be performed to assess the biopsy strategy with the
higher clinical benefit.
