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Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer

NCT05818631 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-04-26

No results posted yet for this study

Summary

The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) \> 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are:

* Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
* Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.

Conditions

Interventions

DIAGNOSTIC_TEST

fusion cognitive prostate biopsy

A standard transrectal prostatic biopsy will be performed to both groups. To the group with suspicious lesions in the MRI (PI-RADS 3-5), an added directed cognitive fusion biopsy will be performed.

Sponsors & Collaborators

  • José Joaquín Mira

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-05-31
Completion
2024-02-29

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818631 on ClinicalTrials.gov