Multivariate Risk Assessment for ISUP ≥2 Prostate CancerPCaRiskNCT04484103
RPCRC Validation Study
An observational study of Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer
- What is being 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.
- How many people
- 275 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Radiology, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69008
About this study
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.
Read more
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.
- Being 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The AUC of the PI-RADS score and the RPCRC significant cancer risk will be calculated at the patient level.
Measured: June 2020
Secondary outcomes (12)
Comparison of the AUC of the PI-RADS score and the RPCRC (detectable cancer risk) for predicting ISUP ≥2 cancer at subsequent biopsy.
The AUC of the Prostate Imaging-Reporting And Data System score and the RPCRC detectable cancer risk will be calculated at the patient level.
Measured: June 2020
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
Measured: June 2020
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
Measured: June 2020
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
Measured: June 2020
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%
Measured: June 2020
AUC of PSA density in predicting ISUP ≥2 cancer at subsequent biopsy.
Measured: June 2020
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
Measured: June 2020
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
Measured: June 2020
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
Measured: June 2020
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.
Measured: June 2020
AUC of the lobe-specific risk calculator developed by our group for predicting ISUP ≥2 cancer at subsequent biopsy.
Measured: June 2020
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.
Measured: June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multivariate Risk Assessment for ISUP ≥2 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484103
- Sponsor's protocol ID
- PCaRisk_2020
- Acronym
- PCaRisk
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the Rotterdam Prostate Cancer Risk Calculator
- ClinicalTrials.gov ID
- NCT04484103
- Acronym / sponsor ID
- PCaRisk / PCaRisk_2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 251 patients from the MRI-FIRST trial | – | 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 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 251 patients from the MRI-FIRST trial |
Primary outcome
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.
Time frame: June 2020
The AUC of the PI-RADS score and the RPCRC significant cancer risk will be calculated at the patient level.
12 secondary outcomes
Comparison of the AUC of the PI-RADS score and the RPCRC (detectable cancer risk) for predicting ISUP ≥2 cancer at subsequent biopsy.
Time frame: June 2020
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
Time frame: June 2020
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
Time frame: June 2020
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
Time frame: June 2020
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%
Time frame: June 2020
AUC of PSA density in predicting ISUP ≥2 cancer at subsequent biopsy.
Time frame: June 2020
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
Time frame: June 2020
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
Time frame: June 2020
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
Time frame: June 2020
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.
Time frame: June 2020
AUC of the lobe-specific risk calculator developed by our group for predicting ISUP ≥2 cancer at subsequent biopsy.
Time frame: June 2020
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.
Time frame: June 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: June 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.