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RPCRC Validation Study

NCT04484103 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2020-07-23

No results posted yet for this study

Summary

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.

Conditions

  • Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer

Interventions

OTHER

Assessment of the diagnostic performance of the PI-RADS score (as a stand-alone) and of the RPCRC for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in 251 patients.

The following features will be retrieved from the CRFs of the patients included in the MRI-FIRST trial: age, DRE findings, PSA level, prostate volume, maximal PI-RADS score; the history of biopsy will be set to a default value of "none" since all patients included in the MRI-FIRST trial were biopsy naïve. Then, the RPCRC will be used to calculate two different risks: the risk of "detectable prostate cancer" and of "significant prostate cancer" (ISUP ≥2) at subsequent biopsy. The PI-RADS score (as a stand-alone) and the risks predicted by the RPCC will be compared to the results of the prostate biopsy performed during the MRI-FIRST trial. Throughout the study, the version 2 of the PI-RADS score will be used.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-04-01
Completion
2020-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484103 on ClinicalTrials.gov