Prostate DiseaseNCT05470127
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
A study testing Prostate biopsy needle in people with Prostate Disease and Prostate CA, run by Uro-1 Medical at 1 site in United States.
Trial summary
Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Disease, Prostate CA
- What is being tested?
- Prostate biopsy needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male scheduled for prostate biopsy
- Able to provide informed consent
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Who cannot join
- Unwilling to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgia Urology
Cartersville, Georgia, 30115
Jeffrey Proctor, MD, 7706071893, jproctor@gaurology.com
Jeffrey Proctor, MD
About this study
Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.
Read the detailed description
The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.
- Conditions
- Prostate Disease, Prostate CA
- Being tested
- Prostate biopsy needle
- Keywords
- Prostate CA, Needle biopsy
- Medical subject headings
- Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsy needleDevice
Prostate tissue biopsy with a biopsy needle
| Study group | Role | What they receive |
|---|---|---|
| SUREcore biopsy needle | Experimental | The SUREcore needle will be used to collect up to 10 tissue samples Receives: Device: Prostate biopsy needle |
| Standard of Care biopsy needle | Active comparator | The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples Receives: Device: Prostate biopsy needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
Percentage of tissue samples collected that are suitable for pathological review
Measured: 1 Day of the procedure
Core length of tissue in the sample
Quantity of Tissue Samples Collected
Measured: 1 Day of the procedure
weight of tissue in the sample
Quantity of Tissue Samples Collected
Measured: 1 Day of the procedure
Tissue Sample Preparation
Time required to prepare the tissue samples for pathological review
Measured: 1 Day of the procedure
Secondary outcomes (1)
Ease of use of the biopsy needle
Utility of the biopsy needle measured with a Likert scale of 1 to 5
Measured: 1 Day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Aug 2022
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate DiseaseStudies 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
- The two biopsy needle sets will be used in the same patient during the procedure.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro-1 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lawson, PhD, Study director, Lawson & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470127
- Sponsor's protocol ID
- SUREcore v. SOC
- Status last verified
- May 2025
- First submitted
- 11 Jul 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Likert scale means for use of either of the biopsy needles will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
- ClinicalTrials.gov ID
- NCT05470127
- Acronym / sponsor ID
- SUREcore v. SOC
- Conditions
- Prostate Disease, Prostate CA
- Keywords
- Prostate CA, Needle biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uro-1 MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 2022 (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.
Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.
Detailed description
The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two biopsy needle sets will be used in the same patient during the procedure.
| Arm | Type | Receives |
|---|---|---|
| SUREcore biopsy needle | Experimental | Device: Prostate biopsy needleThe SUREcore needle will be used to collect up to 10 tissue samples |
| Standard of Care biopsy needle | Active comparator | Device: Prostate biopsy needleThe urologist will use his/her standard biopsy needle to collect up to 15 tissue samples |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male scheduled for prostate biopsy
- Able to provide informed consent
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Key exclusion criteria (1 listed)
- Unwilling to provide consent
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 |
|---|---|---|
| Prostate biopsy needleProstate tissue biopsy with a biopsy needle | Device | SUREcore biopsy needle, Standard of Care biopsy needle |
Primary outcome
Procedure Success
Time frame: 1 Day of the procedure
Percentage of tissue samples collected that are suitable for pathological review
Core length of tissue in the sample
Time frame: 1 Day of the procedure
Quantity of Tissue Samples Collected
weight of tissue in the sample
Time frame: 1 Day of the procedure
Quantity of Tissue Samples Collected
Tissue Sample Preparation
Time frame: 1 Day of the procedure
Time required to prepare the tissue samples for pathological review
1 secondary outcome
Ease of use of the biopsy needle
Time frame: 1 Day of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided. Likert scale means for use of either of the biopsy needles will be available upon request
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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.
Thomas Lawson, PhD study director
Lawson & Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy needle in people with Prostate Disease and Prostate CA, run by Uro-1 Medical at 1 site in United States.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lawson, PhD (5102061794, drthomlawson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: 1 Day of the procedure). The study lists 4 primary outcomes in all. 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 7 May 2025.