Optimizing the Number of Systematic COres During a MRI Target Biopsy

Launched by IRCCS SAN RAFFAELE · Nov 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the best number of tissue samples, called cores, to take during a biopsy for men who may have prostate cancer. The trial involves men aged 18 to 80 who have a positive MRI showing a suspicious area in the prostate. Participants will first receive a targeted biopsy of the suspicious area, followed by additional systematic sampling to see if fewer total samples can still effectively detect significant cancer. The goal is to find out if taking fewer systematic samples can still find the same amount of important cancer, which would help make the biopsy process shorter and safer for patients.

To be eligible for this trial, men must be diagnosed with a suspicious area on their MRI and have a prostate-specific antigen (PSA) level below 20. They should not have had a previous biopsy or treatment for prostate cancer and must be able to understand the study and give consent. Participants can expect to undergo a biopsy where tissue samples will be collected and carefully numbered for analysis. This study aims to improve the biopsy procedure, potentially reducing risks and unnecessary treatments related to less significant cancer findings.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male patients, aged between 18 and 80 years old with suspicion of prostate cancer
• • Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3)
• • Serum PSA ≤ 20ng/ml
• • Suspected stage ≤ T2 on rectal examination (organ confined prostate)
• • Fit to undergo a prostate biopsy
• • Able to understand and willing to sign a written informed consent document
• Exclusion Criteria:
• • Prior positive prostate biopsy
• • Prior treatment of the prostate
• • Prostate volume \<30 ml at mpMRI of the prostate
• • More than one lesion at mpMRI of the prostate
• • Contraindication to prostate biopsy