Trans-Perineal Grid Technique for Prostate Biopsy

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Metal implant, Non-skin malignancy, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Trans-Perineal Grid Technique for Prostate Biopsy?

Research shows that the transperineal approach for prostate biopsy, which includes the grid technique, has a lower risk of infection compared to the transrectal method. It also allows for more accurate mapping and targeting of suspicious areas in the prostate, improving the precision of the biopsy. ^{1 2 3 4 5}

Is the trans-perineal grid technique for prostate biopsy safe?

The trans-perineal grid technique for prostate biopsy is generally considered safe, with studies showing a low rate of complications. One study reported complications in only 2.48% of patients, and another highlighted a lower risk of infections compared to other methods. ^{1 5 6 7 8}

How does the Trans-Perineal Grid Technique for Prostate Biopsy differ from other treatments?

The Trans-Perineal Grid Technique for Prostate Biopsy is unique because it involves a trans-perineal approach, which means the biopsy is taken through the skin between the anus and scrotum, potentially reducing infection risk compared to the more common transrectal method. ^{9 10 11 12 13}

Research Team

David Woodrum, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals scheduled for an MR-guided prostate biopsy or ablation, who have 1-3 suspicious tumor regions on MRI and can consent to the study. They must tolerate anesthesia/sedation. Those with conditions not compatible with MRI or a history of non-skin cancer in the last three years cannot participate.

Inclusion Criteria

I am scheduled for a biopsy or ablation guided by MRI.

One, two, or three tumor suspicious regions identified on multiparametric MRI.

Ability to give informed consent.

Exclusion Criteria

Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.

I have had cancer other than skin cancer in the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo a prostate biopsy or ablation procedure using the trans-perineal guide grid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

• Trans-Perineal Grid

Trial Overview The study is testing a new needle guide grid called Clear Guide SCENERGY - MR, which has VisiMARKER II to help automatically register and target the prostate during biopsies or ablations, aiming to improve needle placement accuracy.

Participant Groups

Group I: Trans-Perineal Grid for prostate interventions Experimental Treatment 1 Intervention

Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Clear Guide Medical Inc.

Collaborator

Trials

1

Recruited

20+

References

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

Freehand Transperineal Prostate Biopsy with Three-Dimensional Ultrasound Organ-Based Tracking. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Bioptic ultrasound-guided prostate remapping (fan shape) using grid software for brachytherapy. [2016]

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

A Novel Perineal Nerve Block Approach for Transperineal Prostate Biopsy: An Anatomical Analysis-based Randomized Single-blind Controlled Trial. [2022]

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

Sonographically guided transperineal prostatic biopsy: preliminary experience with a longitudinal linear-array transducer. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Transperineal template-guided prostate biopsy: 10 years of experience. [2019]

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

Safety and side effects of transperineal prostate biopsy without antibiotic prophylaxis. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

[Morbidity of transperineal echo-guided prostatic biopsy, our experience]. [2016]

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

The role of a standardized 36 core template-assisted transperineal prostate biopsy technique in patients with previously negative transrectal ultrasonography-guided prostate biopsies. [2019]

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

Studies of soil-water transport by MRI. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Sensitivity of the solution of the Elder problem to density, velocity and numerical perturbations. [2007]

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

Delineation of three-dimensional well capture zones for complex multi-aquifer systems. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Panoramic azimuthal Schlumberger Vertical Electrical Sounding for fracture orientation and anisotropy quantification. [2020]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Quantitative imaging of contaminant distributions in heterogeneous porous media laboratory experiments. [2006]