Trans-Perineal Grid Technique for Prostate Biopsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new technique, the Trans-Perineal Grid, to improve needle placement for prostate procedures using a special grid and imaging technology. The goal is to help doctors accurately target the prostate during biopsies or treatments. Suitable candidates for this trial include individuals scheduled for an MRI-guided prostate biopsy or treatment, with suspicious areas identified on MRI scans. This trial may benefit those who can undergo anesthesia and have no metal in their body that would interfere with an MRI. As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance the accuracy of prostate procedures.
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 prior data suggests that this technique is safe for prostate interventions?
A previous study found the Trans-Perineal Grid method for prostate biopsy safer than the traditional Trans-Rectal method. Research shows it significantly lowers the risk of infections, such as urinary tract infections and sepsis, and reduces the chances of rectal bleeding and fever. Specifically, one study reported that about 4.4% of patients experienced side effects with the trans-perineal method, compared to 8.9% with the trans-rectal approach. Overall, this method is well-tolerated and has fewer side effects, making it a safer option for prostate procedures.12345
Why are researchers excited about this trial?
Researchers are excited about the trans-perineal grid technique for prostate biopsies because it offers a more precise and potentially safer alternative to traditional biopsy methods, like the transrectal approach. This technique uses a grid to guide the biopsy needle through the perineum, which reduces the risk of infection as it avoids the rectum entirely. Additionally, this method can provide better access to all parts of the prostate, potentially leading to more accurate diagnoses.
What evidence suggests that the Trans-Perineal Grid technique is effective for prostate interventions?
Research has shown that transperineal prostate biopsies are as effective as transrectal ones in detecting prostate cancer, with about a 70% success rate. A major benefit of the transperineal method, which participants in this trial will undergo using the Trans-Perineal Grid technique, is its safety. Studies indicate it significantly reduces the risk of complications like rectal bleeding, infections, and sepsis compared to the transrectal method. Additionally, this approach may better detect cancers in certain areas of the prostate, such as the front, suggesting it could be a more reliable choice for some patients.12467
Who Is on the Research Team?
David Woodrum, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo a prostate biopsy or ablation procedure using the trans-perineal guide grid
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Trans-Perineal Grid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Clear Guide Medical Inc.
Collaborator