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

José Joaquín Mira

Status: Enrolling

Conditions: Prostate Cancer Diagnosis; Prostate Cancer

Treatments: Diagnostic Test: fusion cognitive prostate biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05818631

Prostate MRI FAST protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Not having all the inclusion criteria described
• 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

Trial design

300 participants in 2 patient groups

MRI +

Description:

PI-RADS 3-5

Treatment:

Diagnostic Test: fusion cognitive prostate biopsy

MRI -

Description:

PI-RADS 1-2