Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies

NCT ID: NCT06907446

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-01

Brief Summary

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To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with \~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study comparing two different needle biopsy systems for prostate biopsy

Group Type OTHER

Comparison of Biopsy Needle Types for Prostate Biopsy

Intervention Type DIAGNOSTIC_TEST

Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle

Interventions

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Comparison of Biopsy Needle Types for Prostate Biopsy

Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient older than age of 18 undergoing prostate biopsy

Exclusion Criteria

* Unable to consent
* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Davis Departments of Urologic Oncology

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marc Dall'Era, MD

Role: CONTACT

916-734-2893

Elisa Lee

Role: CONTACT

916-734-5173

Facility Contacts

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Marc Dall'Era, MD

Role: primary

916-734-2893

Other Identifiers

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2262703

Identifier Type: -

Identifier Source: org_study_id

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