Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate Clinical Trial
Official title:
Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
| NCT number | NCT04183699 |
| Other study ID # | SCOT |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 6, 2019 |
| Est. completion date | June 30, 2025 |
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.
| Status | Recruiting |
| Enrollment | 265 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS San Raffaele | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy | Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy | through study completion, an average of 1 year | |
| Secondary | Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy | The proportion of men diagnosed with csPCa according to the addition of any single systematic core | through study completion, an average of 1 year |