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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new biopsy needle, the SUREcore Biopsy Needle, designed to obtain better tissue samples for diagnosing prostate cancer. Diagnosing prostate cancer often involves a biopsy, where a tissue sample is examined for cancer cells. The new needle aims to collect more tissue with each sample, potentially improving doctors' ability to detect and understand the cancer. This trial suits individuals needing a prostate biopsy who wish to help test this new needle. Participants should not have conditions that might affect the trial's results. As an unphased trial, this study offers an opportunity to contribute to medical advancements in prostate cancer diagnosis.

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 prior data suggests that this biopsy needle is safe for prostate cancer detection?

Research shows that the SUREcore biopsy needle is designed to collect more complete tissue samples during prostate biopsies. Studies before human trials found that this needle gathers about 21% more tissue per sample compared to regular needles, potentially improving prostate cancer detection. Although specific safety data for humans isn't available, the needle is designed for greater accuracy and effectiveness. Biopsy needles used in medical procedures undergo thorough testing to ensure safety. If this needle is in an advanced stage of clinical trials, earlier tests deemed it safe for human use. However, discussing potential risks and benefits with the research team before joining any clinical trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SUREcore Biopsy Needle is unique because it offers a new approach to prostate cancer diagnosis through its advanced needle design. Unlike traditional biopsy needles, which can sometimes miss cancerous tissues or cause significant discomfort, the SUREcore needle aims to improve accuracy and patient comfort. Researchers are excited about this technology because it might lead to more precise tissue sampling and potentially detect cancer earlier, making it a promising advancement in prostate cancer diagnostics.

What evidence suggests that the SUREcore Biopsy Needle is effective for prostate cancer detection?

Research has shown that the SUREcore biopsy needle, used by participants in this trial, may greatly enhance prostate cancer detection. One study found that this needle system achieved a 92% accuracy in targeting, compared to 36% with standard needles. This indicates that the SUREcore needle is much more effective at identifying cancer. Additionally, it collects about 21% more tissue per sample, aiding doctors in gaining a clearer understanding of the condition. More tissue can help detect cancer that might be missed with other needles. Overall, evidence suggests that this new needle could significantly improve prostate cancer diagnosis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06907446

Comparison of New SUREcore Biopsy of Needle to ... The primary outcome will evaluate whether cancer is detected on final pathological analysis. This will include the grade of cancer, percentage of core involved, ...

2. 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 ...

3. 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 ...

4. 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 ...

5. 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 ...

6. integrative-cancer-care.org integrative-cancer-care.org/risks-and-benefits-of-needle-biopsy-in-prostate-cancer-diagnosis/

Risks and Benefits of Needle Biopsy in Prostate Cancer ... Evidence shows that biopsies can dislodge cancer cells from the primary tumour along the needle biopsy track, or into the lymph- and bloodstream.