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

Trial Summary

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 data supports the effectiveness of the SUREcore biopsy needle treatment 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 accurate results, which suggests that the SUREcore needle might also be effective in identifying significant prostate cancer. ^{1 2 3 4 5}

Is the SUREcore biopsy needle safe for use in humans?

The 21 gauge Surecut needle, similar to the SUREcore biopsy needle, has been used in prostate biopsies and was able to provide tissue samples for diagnosis in most cases, suggesting it is generally safe for use in humans. ^{2 6 7 8 9}

How is the SUREcore biopsy needle treatment different from other prostate cancer treatments?

The SUREcore biopsy needle is unique because it uses a fine needle system to obtain regular tissue cores for histological evaluation, which can be performed transrectally or transperineally, providing flexibility in approach and potentially improving diagnostic accuracy. ^{2 6 7 8 10}

What is the purpose of this trial?

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.

Research Team

Thomas Lawson, PhD

Principal Investigator

Lawson & Associates

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Detection of Significant Prostate Cancer According to Anatomical Areas of Sampling Cores Obtained with Transrectal Systematic 12-Core Biopsy. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Four regions 12-core systemic prostate biopsy for diagnosis of prostate cancer]. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A prospective randomised trial of extended core prostate biopsy protocols utilizing 12 versus 15 cores. [2009]

4. Canada pubmed.ncbi.nlm.nih.gov

Low accuracy of routine ultrasound-guided systematic 12-core biopsies in prostate tumor mapping. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Extended 12-core prostate biopsy increases both the detection of prostate cancer and the accuracy of Gleason score. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate biopsy quality is independent of needle size: a randomized single-center prospective study. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Pooled outcomes of performing freehand transperineal prostate biopsy with the PrecisionPoint Transperineal Access System. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prostatic biopsy with the 21 gauge Surecut needle. A preliminary report of a new technique. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Patients with low prostate-specific antigen levels ( [2007]

10. England pubmed.ncbi.nlm.nih.gov

A new core-biopsy instrument with an end-cut technique provides prostate biopsies with increased tissue yield. [2019]