New Biopsy Needle for Prostate Cancer

Overseen By Marc Dall'Era, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Unable to consent, prisoners, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this 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 21 gauge Surecut needle, similar to the SUREcore Biopsy Needle, has been shown to effectively obtain tissue samples for prostate cancer diagnosis in most cases, suggesting its potential effectiveness in providing reliable biopsy results. ^{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 is considered safe, as no complications were reported in a study involving 13 patients. Additionally, 16 gauge needles, which are similar in function, have been shown to improve specimen quality without increasing patient discomfort or complications. ^{1 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 provide regular tissue cores for diagnosis, potentially offering a less invasive option with a smaller needle size compared to traditional methods. This can lead to reduced pain and complications during prostate biopsies. ^{1 4 7 10 11}

Eligibility Criteria

This trial is for men over 18 who need a prostate biopsy. It's not suitable for those unable to consent or with health issues that could interfere with the study, as judged by the researcher.

Exclusion Criteria

Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives

Prisoners

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy Procedure

Participants undergo a transperineal prostate biopsy using the SureCore biopsy needle system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

up to 1 year

Treatment Details

Interventions

• SUREcore Biopsy Needle

Trial Overview The study compares a new type of biopsy needle called SUREcore to standard needles during transperineal prostate biopsies, aiming to see if it can get more intact tissue and improve cancer detection.

Participant Groups

Group I: Single arm study comparing two different needle biopsy systems for prostate biopsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Prediction of prostate cancer in extended-field biopsies of the prostate. [2019]

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

The roles of fine needle aspiration and needle core biopsies in the diagnosis of primary prostatic cancer. [2019]

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

Percent of prostate needle biopsy cores with cancer is significant independent predictor of prostate specific antigen recurrence following radical prostatectomy: results from SEARCH database. [2009]

6. Canada pubmed.ncbi.nlm.nih.gov

How reliable is 12-core prostate biopsy procedure in the detection of prostate cancer? [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Sixteen gauge needles improve specimen quality but not cancer detection rate in transrectal ultrasound-guided 10-core prostate biopsies. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Transrectal needle aspiration versus transperineal needle biopsy in diagnosis of prostatic carcinoma. [2019]

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]

11. Iran pubmed.ncbi.nlm.nih.gov

Diagnostic Yield and Complications Using a 20 Gauge Prostate Biopsy Needle versus a Standard 18 Gauge Needle: A Randomized Controlled Study. [2022]