NCT05818631

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

Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: José Joaquín Mira · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-05-01
• Completion: 2024-02-01
• First posted: 2023-04-19
• Last updated: 2023-04-26

Locations

1 site across 1 country: Spain