NCT04484103: PCaRisk

RPCRC Validation Study

Status unknown Last updated 23 July 2020

What this trial tests

trial testing 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. in Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer in 275 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
1 April 2020

1 September 2020

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	275
Start date	1 January 2020
Primary completion	1 April 2020
Estimated completion	1 September 2020
Sites	1 location across France

Drugs / interventions tested

• 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.

Conditions studied

• Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer — all drugs for Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 75, male only, with Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.