Prostate BiopsyNCT03413137
Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
A study testing Transperineal mpMRI-US Fusion prostate biopsy and Transrectal mpMRI-US Fusion prostate biopsy in people with Prostate Biopsy, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Transperineal mpMRI-US Fusion prostate biopsy and Transrectal mpMRI-US Fusion prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Dec 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
- Either primary biopsy or repeated biopsy
- Age 18-90.
- PI-RADS classification of 3-5
Who cannot join
- Men who do not have an MRI of the prostate.
- PI-RADS classification of 2 or lower
- Men who were diagnosed with prostate cancer and have begun treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Beilinson campus
Petah Tikva, 4941492
Sivan Sela, B.Sc, +972-3-9376553, Sivanto1@clalit.org.il
Tzlil Tabachnik, M.Sc, +972-3-9376553, Tzlilba1@clalit.org.il
About this study
Official title: A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy
Read the detailed description
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).
First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.
The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
- Conditions
- Prostate Biopsy
- Being tested
- Transperineal mpMRI-US Fusion prostate biopsy, Transrectal mpMRI-US Fusion prostate biopsy
- Keywords
- Prostate cancer, transperineal mp-MRI-fusion/TRUS biopsies, mp-MRI fusion/TRUS transrectal biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal mpMRI-US Fusion prostate biopsyProcedure or surgery
Also called MRI-US Fusion TP
mpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI).
Transrectal mpMRI-US Fusion prostate biopsyProcedure or surgery
Also called MRI-US Fusion TR
using the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy Receives: Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy |
| Arm B | Active comparator | A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy Receives: Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate for clinically significant prostate cancer
To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
Measured: within 2 years
Secondary outcomes (2)
Percentage of cores positive per region of interest (ROI)
To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Percentage of cores positive per region of interest (ROI)
Measured: within 2 years
Amount of volume of cores positive per region of interest (ROI)
To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Amount of volume of cores positive per region of interest (ROI)
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start11 Dec 2017
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD PhD, Principal investigator, Rabn Medical Center, Beilinson Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413137
- Sponsor's protocol ID
- 0618-17-RMC
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
- ClinicalTrials.gov ID
- NCT03413137
- Acronym / sponsor ID
- 0618-17-RMC
- Conditions
- Prostate Biopsy
- Keywords
- Prostate cancer, transperineal mp-MRI-fusion/TRUS biopsies, mp-MRI fusion/TRUS transrectal biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy
Detailed description
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).
First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.
The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: Transperineal mpMRI-US Fusion prostate biopsy, Procedure: Transrectal mpMRI-US Fusion prostate biopsyA Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy |
| Arm B | Active comparator | Procedure: Transperineal mpMRI-US Fusion prostate biopsy, Procedure: Transrectal mpMRI-US Fusion prostate biopsyA Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
- Age 18-90.
- PI-RADS classification of 3-5
Key exclusion criteria (3 listed)
- Men who do not have an MRI of the prostate.
- PI-RADS classification of 2 or lower
- Men who were diagnosed with prostate cancer and have begun treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal mpMRI-US Fusion prostate biopsyAlso: MRI-US Fusion TPmpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI). | Procedure or surgery | Arm A, Arm B |
| Transrectal mpMRI-US Fusion prostate biopsyAlso: MRI-US Fusion TRusing the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging. | Procedure or surgery | Arm A, Arm B |
Primary outcome
Detection rate for clinically significant prostate cancer
Time frame: within 2 years
To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
2 secondary outcomes
Percentage of cores positive per region of interest (ROI)
Time frame: within 2 years
Amount of volume of cores positive per region of interest (ROI)
Time frame: within 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD PhD principal investigator
Rabn Medical Center, Beilinson Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal mpMRI-US Fusion prostate biopsy and Transrectal mpMRI-US Fusion prostate biopsy in people with Prostate Biopsy, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sivan Sela, B.Sc (+972(0)3-9376553, Sivanto1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate for clinically significant prostate cancer (time frame: within 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.