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

NCT ID: NCT05818631

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-02-29

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.

Detailed Description

In Spain, PCa is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. Incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern.

PCa generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated Prostate Specific Antigen (PSA) in blood test and/or a pathologic digital rectal examination.

Multiparametric Magnetic Resonance Imaging (MRImp) plays an important role in the diagnosis. It allows the visualization of the tumor, it values its agresitivity with a scale named "Prostate Imaging-Reporting and Data System" (PI-RADS v2 scale), and permits a directed biopsy to the suspicious lesion.

This tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. Due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with PCa suspicion.

Biparametric MRI emerges as an alternative with a new protocol, performed with less image sequences (T2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. Thus, this technique is more assumable by a public sanitary system.

Conditions

Prostate Cancer; Prostate Cancer Diagnosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

MRI +

PI-RADS 3-5

fusion cognitive prostate biopsy

Intervention Type: 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.

MRI -

PI-RADS 1-2

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

directed prostate biopsy

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

José Joaquín Mira

OTHER

Sponsor Role: lead

Responsible Party

José Joaquín Mira

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universidad Miguel Hernández de Elche

Alicante, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

BARAA NAKDALI KASSAB

Role: CONTACT

baranakdali@hotmail.com

663292199

Facility Contacts

BARAA NAKDALI KASSAB

Role: primary

baranakdali@hotmail.com

663292199

Other Identifiers

Prostate MRI FAST protocol

Identifier Type: -

Identifier Source: org_study_id