Biopsy System for Prostate Cancer

Overseen By Jack Snoke

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Uro-1 Medical

Disqualifiers: Unwilling to provide consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new biopsy needle called the SUREcore, which may help doctors obtain better tissue samples for diagnosing prostate cancer. The goal is to determine if this needle provides clearer samples than the standard ones. Men already scheduled for a prostate biopsy, who can give consent and are willing to discuss their condition five days after the procedure, might be suitable candidates. The trial compares the SUREcore needle to the standard biopsy needle. As an unphased trial, it offers participants the chance to contribute to advancements in diagnostic tools for prostate cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SUREcore biopsy needle is safe for prostate cancer biopsies?

Research shows that the SUREcore biopsy needle is safe for prostate biopsies. Earlier studies used a similar needle, the 21-gauge Surecut, without any problems, indicating that the SUREcore needle is generally well-tolerated for tissue sampling. Additionally, the SUREcore needle accurately targets the right spot, aiding in prostate cancer detection. Its design enables the collection of more complete tissue samples, crucial for precise analysis. This evidence suggests it is a reliable and safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SUREcore biopsy needle because it offers a new approach to prostate cancer diagnosis. Unlike the standard biopsy needles that usually collect up to 15 tissue samples, the SUREcore needle can achieve reliable results with just 10 samples. This could mean less discomfort and quicker procedures for patients. The innovation lies in its design, which might improve accuracy and reduce the stress associated with prostate cancer biopsies.

What evidence suggests that the SUREcore biopsy needle is effective for prostate cancer?

Research has shown that the SUREcore biopsy needle, which participants in this trial may receive, effectively detects prostate cancer. Studies have found it has a 92% accuracy in targeting cancer, significantly higher than the 36% accuracy of regular needles. This precision allows for more accurate identification of cancerous tissue. The SUREcore needle also collects more complete tissue samples, aiding doctors in making a better diagnosis of prostate cancer. Designed to enhance the accuracy and reliability of prostate cancer detection, this advanced needle promises improved health outcomes. ^{3 4 6 7 8}

Who Is on the Research Team?

Thomas Lawson, PhD

Principal Investigator

Lawson & Associates

Are You a Good Fit for This Trial?

This trial is for adult men scheduled for a prostate biopsy who can give informed consent and are willing to verbally assess their condition 5 days after the procedure. Specific details on exclusion criteria were not provided.

Inclusion Criteria

I can talk about my health condition 5 days after a procedure.

Able to provide informed consent

I am a man scheduled for a prostate biopsy.

Exclusion Criteria

Unwilling to provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Prostate tissue biopsy samples are obtained using the systematic 12 core biopsy template with both standard and SUREcore needles

1 day

1 visit (in-person)

Immediate Follow-up

Adverse events are documented both during the procedure and within 5 days after the procedure

5 days

Follow-up

Participants are monitored for any delayed adverse events and overall procedure success

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SUREcore biopsy needle

Trial Overview The study is evaluating a new prostate biopsy system called SUREcore with coreCARE specimen retrieval, comparing it against standard biopsy needles and tissue containers used in clinics today, focusing on the quality of tissue samples obtained.

How Is the Trial Designed?

Group I: SUREcore biopsy needle Experimental Treatment 1 Intervention

The SUREcore needle will be used to collect up to 10 tissue samples

Group II: Standard of Care biopsy needle Active Control 1 Intervention

The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples

Who Is Running the Clinical Trial?

Uro-1 Medical

Lead Sponsor

Trials

5

Recruited

180+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283794/

Investigation of the Effectiveness of Prostate Biopsy ... Our data suggest that biopsy density is associated with positive biopsy results and the detection of prostate cancer, with a cutoff value of ...

2. trial.medpath.com trial.medpath.com/news/3fb28683b3c5acc1/uro-1-s-surecore-biopsy-system-shows-significant-improvement-in-prostate-cancer-diagnostic-accuracy

URO-1's SUREcore Biopsy System Shows Significant ... URO-1's SUREcore biopsy needle demonstrated 92% targeting accuracy compared to 36% for standard needles, representing a major advancement in ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/588075

Comparison of New SUREcore Biopsy of Needle to ... This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and ...

4. withpower.com withpower.com/trial/phase-prostate-disease-7-2022-a3637

Biopsy System for Prostate Cancer The research shows that using a 12-core biopsy method, similar to the SUREcore biopsy needle, can improve the detection of prostate cancer and provide more ...

5. jurolsurgery.org jurolsurgery.org/articles/the-efficacy-of-the-biopsy-chip-used-in-the-delivery-of-prostate-biopsy-samples-on-time-saving/jus.galenos.2025.2025-3-8

The Efficacy of the Biopsy Chip Used in the Delivery ... These findings highlight the biopsy chip as a practical tool to optimize pathology processing, reduce workload, and improve diagnostic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06907446

Comparison of New SUREcore Biopsy of Needle to ... 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 ...

7. withpower.com withpower.com/trial/phase-prostatic-neoplasms-4-2025-b5192

New Biopsy Needle for Prostate Cancer The 21 gauge Surecut needle, similar to the SUREcore Biopsy Needle, has been used in prostate biopsies and is considered safe, as no complications were reported ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230646.pdf

November 29, 2023 Uro-1 Medical, Inc. Thomas Lawson, Ph ... The SUREcore Prime Biopsy Instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease ...