RPCRC Validation Study

NCT ID: NCT04484103

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-09-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

251 patients from the MRI-FIRST trial

The mpMRIs were performed at 16 centers with 1.5T or 3T MR units. All mpMRIs included T2-weighted imaging, diffusion-weighted imaging and dynamic contrast-enhanced imaging.

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.

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient referred for mpMRI and prostate biopsy due to increased PSA level, abnormal DRE or family history of prostate cancer.
• Age ≤75 years
• PSA level ≤20 ng/mL
• Clinical stage ≤T2c

Exclusion Criteria

• Contraindication for prostate mpMRI or biopsy
• History of hip prosthesis, androgen deprivation therapy, pelvic radiotherapy or prostate cancer diagnosed after trans-urethral resection of the prostate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Radiology, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, , France

Countries

France

Other Identifiers

PCaRisk_2020

Identifier Type: -

Identifier Source: org_study_id