- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183699
Optimizing the Number of Systematic COres During a MRI Target Biopsy
March 29, 2022 updated by: Prof. Alberto Briganti, IRCCS San Raffaele
Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
265
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marta Picozzi
- Phone Number: +390226436268
- Email: picozzi.marta@hsr.it
Study Locations
-
-
-
Milan, Italy, 20132
- Recruiting
- IRCCS San Raffaele
-
Contact:
- Marta Picozzi
- Phone Number: +390226436268
- Email: picozzi.marta@hsr.it
-
Principal Investigator:
- Alberto Briganti, Prof
-
Sub-Investigator:
- Armando Stabile, MD
-
Sub-Investigator:
- Francesco Pellegrino, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MRI targeted + systematic random biopsy
|
MRI-targeted + systematic random prostate biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
Time Frame: 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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsybiopsy
Time Frame: through study completion, an average of 1 year
|
The proportion of men diagnosed with csPCa according to the addition of any single systematic core
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 6, 2019
Primary Completion (ANTICIPATED)
June 30, 2022
Study Completion (ANTICIPATED)
June 30, 2022
Study Registration Dates
First Submitted
November 7, 2019
First Submitted That Met QC Criteria
November 28, 2019
First Posted (ACTUAL)
December 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCOT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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