Prostate Cancer ScreeningNCT06830265
Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
A study testing Novel needle biopsy catheter (test) in people with Prostate Cancer Screening, run by Uro-1 Medical at 3 sites in United States.
Trial summary
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Screening
- What is being tested?
- Novel needle biopsy catheter (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jul 2025to 10 Dec 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males with PSA density greater than or equal to 0.15
- Lesions are visible under MRI
- PIRADS score is greater than or equal to 3
- Able to and willing to provide consent
Who cannot join
- Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
- History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
- Is a prisoner currently or has a history of incarceration
- Unable to understand English
- Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
- Has concurrent malignancies
- Is positive for HIV, HBV, and/or HCV infection
- Has low-performance status
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Jhoanna Z Aquino, 919-660-6189, jhoannazaida.Aquino@duke.edu
Brian Cuffe, BS, 919-681-5557, brian.cuffe@duke.edu
- Recruiting
Novant Health Coastal Carolina Medical Center
Hardeeville, South Carolina, 29927
Kellie A King, RN, 843-706-2255, KFrancisKing@novanthealth.org
Thomas Lawson, PhD, 510-206-1794, drthomlawson@gmail.com
- Active, not recruiting
NYU Langone
New York, New York, 10016
About this study
Official title: Comparing a Standard of Care Prostate Biopsy System With a Novel System Using Standard as Well as Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.
Read the detailed description
Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.
- Conditions
- Prostate Cancer Screening
- Being tested
- Novel needle biopsy catheter (test)
- Keywords
- Randomized Two-arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel needle biopsy catheter (test)Device
Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe. Receives: Device: Novel needle biopsy catheter (test) |
| Single Arm | Active comparator | The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system. Receives: Device: Novel needle biopsy catheter (test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atypical Small Acinar Proliferation
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
Measured: From enrollment to end of treatment at 1 day
Gleason Score
Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
Measured: From enrollment to end of treatment at 1 day
Tissue area and length
The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
Measured: From treatment to end of pathology review at 2 days
Tissue toruosity
Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.
Measured: From treatment to end of pathology review at 2 days
Secondary outcomes (1)
Standard Pathology versus Computational Pathology Results
Tissue samples will be analyzed by standard pathology techniques and computational pathology and differences in values of diagnosis, Gleason score, percent tumor volume, presence of cribiform glands, and perineural invasion compared
Measured: From treatment to end of pathology review at 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start7 Jul 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer ScreeningStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Each patient enrolled will have prostate biopsy completed with a standard of care needle biopsy system (control) and a novel needle biopsy system (test), each targeting separate regions of the prostate.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro-1 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, NYU Langone Health, Novant Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Lawson, Study director, Uro-1 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830265
- Sponsor's protocol ID
- 25-001
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Standard of Care Prostate Biopsy System With a Novel System Using Standard as Well as Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.
- ClinicalTrials.gov ID
- NCT06830265
- Acronym / sponsor ID
- 25-001
- Conditions
- Prostate Cancer Screening
- Keywords
- Randomized Two-arm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uro-1 MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, NYU Langone Health, Novant Health, Inc.
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.
Detailed description
Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient enrolled will have prostate biopsy completed with a standard of care needle biopsy system (control) and a novel needle biopsy system (test), each targeting separate regions of the prostate.
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Device: Novel needle biopsy catheter (test)The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe. |
| Single Arm | Active comparator | Device: Novel needle biopsy catheter (test)The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males with PSA density greater than or equal to 0.15
- Lesions are visible under MRI
- PIRADS score is greater than or equal to 3
- Able to and willing to provide consent
Key exclusion criteria (8 listed)
- Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
- History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
- Is a prisoner currently or has a history of incarceration
- Unable to understand English
- Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
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 |
|---|---|---|
| Novel needle biopsy catheter (test)Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample | Device | Single Arm, Test group |
Primary outcome
Atypical Small Acinar Proliferation
Time frame: From enrollment to end of treatment at 1 day
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
Gleason Score
Time frame: From enrollment to end of treatment at 1 day
Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
Tissue area and length
Time frame: From treatment to end of pathology review at 2 days
The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
Tissue toruosity
Time frame: From treatment to end of pathology review at 2 days
Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.
1 secondary outcome
Standard Pathology versus Computational Pathology Results
Time frame: From treatment to end of pathology review at 2 days
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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 study director
Uro-1 Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel needle biopsy catheter (test) in people with Prostate Cancer Screening, run by Uro-1 Medical at 3 sites 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 4 inclusion and 8 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 (510-206-1794, tlawson@uro1medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atypical Small Acinar Proliferation (time frame: From enrollment to end of treatment at 1 day). 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 4 Sep 2026.