Multivariate Risk Assessment for ISUP =2 Prostate Cancer Clinical Trial
Official title:
External Validation of the Rotterdam Prostate Cancer Risk Calculator
Prostate multiparametric MRI (mpMRI) can detect ISUP ≥2 prostate cancer with high
sensitivity. Adding biopsies targeting suspicious lesions seen on mpMRI to the classical
'systematic biopsies' (that sample the gland in a blinded way) improves the detection of ISUP
≥2 cancers. As a result, it is now recommended to perform a prostate mpMRI before biopsy and
to combine targeted and systematic biopsy.
However, mpMRI suffers from a lack of specificity. In a recent meta-analysis, the pooled
sensitivity and specificity of prostate mpMRI for detecting ISUP ≥2 cancers were 0.91 (95%
confidence interval, 0.83-0.95) and 0.37 (95% confidence interval, 0.29-0.46) respectively.
Thus, accurate triage of patients suitable for biopsy might not be possible using mpMRI
findings alone.
The Rotterdam Prostate Cancer Risk Calculator (RPCRC) combines mpMRI results (Prostate
Imaging-Reporting And Database System score) and basic clinical and biochemical data to
predict the results of prostate biopsy. If validated, this tool could help selecting patients
for prostate biopsy.
In this study, the investigators propose to retrospectively use the data of the prospective
multicentric MRI-FIRST trial (NCT0285379) to perform an external validation of the RPCRC.
In addition, the PCaRisk study has two secondary objectives:
- To confirm that Prostate Specific Antigen density (i.e. PSA level divided by prostate
volume) can stratify the risk of ISUP ≥2 cancer in patients with negative (PI-RADS 1-2)
or inconclusive (PI-RADS 3) mpMRI, as suggested by recent literature
- To perform a preliminary evaluation of a lobe-specific risk calculator developed by our
group and combining mpMRI results and clinical and biochemical data to predict the risk
of ISUP ≥2 cancer at the lobe level.
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