Clinical trial NCT04484103: RPCRC Validation Study
Official title: External Validation of the Rotterdam Prostate Cancer Risk Calculator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 275
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the MRI-FIRST trial, i.e. biopsy-naïve patients referred for suspicion of prostate cancer on the basis of increased PSA level, abnormal DRE or family history of prostate cancer, recruited in 16 different centers in France, and who underwent mpMRI before systematic and targeted biopsy.

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.


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.

Primary outcomes:
measure: Comparison of the Area Under Curve of the PI-RADS score and the RPCRC (significant cancer risk) for predicting ISUP ≥2 cancer at subsequent biopsy.
timeFrame: June 2020
Secondary outcomes:
measure: Comparison of the AUC of the PI-RADS score and the RPCRC (detectable cancer risk) for predicting ISUP ≥2 cancer at subsequent biopsy.
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if PIRADS cut-off values of ≥3 and ≥4 were used as biopsy triggers
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if RPCRC detectable cancer risk cut-off values of ≥12.5% and ≥20% were used as biopsy triggers
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if RPCRC significant cancer risk cut-off value of ≥4% was used as biopsy trigger
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if biopsy was performed only in patients with a RPCRC detectable cancer risk ≥20%, or with a RPCRC detectable cancer risk ≥12.5% and a RPCRC significant cancer risk ≥4%
timeFrame: June 2020
measure: AUC of PSA density in predicting ISUP ≥2 cancer at subsequent biopsy.
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if PSA density cut-off values of ≥0.15 ng/ml² and ≥0.20 ng/ml² were used as biopsy triggers
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if biopsy was performed only in patients with a PI-RADS score ≥4, or with a PI-RADS score ≤3 and a PSA density ≥0.15 ng/ml²
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and missed ISUP ≥2 cancers if biopsy was performed only in patients with a PI-RADS score ≥4, or with a PI-RADS score ≤3 and a PSA density ≥0.20 ng/ml²
timeFrame: June 2020
measure: Net benefice (Decision curve analysis) for cut-off values of ≥12.5% and ≥20% for the RPCRC detectable cancer risk, of ≥4% for the RPCRC significant cancer risk, and of ≥0.15 ng/ml² and ≥0.20 ng/ml² for PSA density.
timeFrame: June 2020
measure: AUC of the lobe-specific risk calculator developed by our group for predicting ISUP ≥2 cancer at subsequent biopsy.
timeFrame: June 2020
measure: Number of avoided biopsies, missed ISUP 1 cancers and ISUP ≥2 cancers (at patient level) if only lobes with a lobe-specific risk of having ISUP ≥2 cancers ≥5%, ≥10% and ≥15% were biopsied.
timeFrame: June 2020
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Radiology, Hôpital Edouard Herriot, Hospices Civils de Lyon
Study officials:
References: