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

NCT05818631 | Unknown

• 1 other identifier: Prostate MRI FAST protocol
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Prostate Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic precision of Biparametric Magnetic Resonance Imaging: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging

  evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer in patients with biochemical suspicion of prostate cancer (Prostate Specific Antigen in blood test \> 4 ng/mL) with a normal digital rectal examination and without a biopsy previous to the MRI

  1 hour

Secondary Outcomes (1)

• Validity of first directed transrectal prostatic biopsy: consecutive validation of two diagnostic tests for obtaining sensitivity, specificity, positive predictive value and negative predictive value of the biparametric magnetic resonance imaging

  1 hour

Study Arms (2)

MRI +

PI-RADS 3-5

Diagnostic Test: fusion cognitive prostate biopsy

MRI -

PI-RADS 1-2

Interventions

fusion cognitive prostate biopsy DIAGNOSTIC_TEST

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.

Also known as: directed prostate biopsy

MRI +

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in the 17th department of the Valencian Community (San Juan de Alicante's Department). Main patients are those that visit the consultation room in the Urological department of the Hospital Universitario San Juan de Alicante.

You may qualify if:

• Male patients between 18 and 80 years
• BpMRI performed in a 3 months period before the prostatic biopsy
• First transrectal prostatic biopsy
• PSA \> 4 ng/mL and \< 20 ng/mL
• Patients acceptance to participate in the study signing a written specific informed consent

You may not qualify if:

• Suspicious digital rectal examination of prostate cancer
• Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter
• Previous prostatic surgery in any of its variants
• Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors

Sponsors & Collaborators

• José Joaquín Mira: lead

Study Sites (1)

Universidad Miguel Hernández de Elche

Alicante, 03550, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

BARAA NAKDALI KASSAB

CONTACT

663292199; baranakdali@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 19, 2023
• Study Start: March 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: February 1, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

ES (1)