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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818631
• Other study ID #: Prostate MRI FAST protocol
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Universidad Miguel Hernandez de Elche
• Contact: BARAA NAKDALI KASSAB
• Phone: 663292199
• Email: baranakdali[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Diagnosis
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernández de Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
José Joaquín Mira

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	1 hour