Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTProstate biopsy
MRI-targeted + systematic random prostate biopsy
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy | through study completion, an average of 1 year | Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy | through study completion, an average of 1 year | The proportion of men diagnosed with csPCa according to the addition of any single systematic core |
Countries
Italy
Outcome results
None listed