Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03960112

Acronym

NPV-MRI-02

Enrollment

150

Registered

2019-05-22

Start date

2020-10-01

Completion date

2022-12-01

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

multiparametric MRI, cystoprostatectomy

Brief summary

To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Detailed description

To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Interventions

DEVICEmpMRI

mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Per patient analysis in a prospective, multicenter cohort, open study.

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. age \>18 years 2. male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer (clinical T2-T3, any N) or high risk non-muscle invasive bladder cancer (pT1 or CIS) 3. no known diagnosis of prostate cancer 4. no contraindication to undergo multiparametric MRI 5. Signed written informed consent prior to any screening procedures being performed 6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen

Exclusion criteria

1. allergy against MR contrast media 2. diagnosis or previous treatment of prostate cancer 3. severe renal insufficiency (GFR \<30ml/min) 4. Bladder cancer infiltrating the prostate (T4) 5. Pelvic metallic implants such as hip prosthesis 6. Patients scheduled for cystoprostatectomy with prostate capsule sparing 7. Patients unable to provide informed consent 8. Patients having a prostate biopsy \<6 month

Design outcomes

Primary

Measure	Time frame	Description
Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference	From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days)	The true negative and false negative rates of mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen as a reference in patients with no previous diagnosis of prostate cancer.

Countries

France

Contacts

Primary ContactDominique GENRE, MD

DRCI.UP@ipc.unicancer.fr33 (0)4 91 22 37 78

Backup ContactMargot BERLINE, MSc, MBA

BERLINEM@ipc.unicancer.fr33 (0)4 91 22 33 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026