Identifying the Optimal Biopsy Scheme at MRI Target Biopsy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Contact Information
Primary
Armando Stabile
stabile.armando@hsr.it
+390226435660
Backup
Lucia Dambrosio
dambrosio.lucia@hsr.it
+390226435660
Time Frame
Start Date: 2019-06-06
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 265
Treatments
Experimental: MRI targeted + systematic random biopsy
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov