Barrigel + Cryoablation for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Barrigel, a gel-like spacer, to determine if it can protect the rectum during prostate cryoablation, a procedure that freezes and destroys cancer cells. The goal is to assess whether Barrigel remains stable and safe during treatment for localized or returning prostate cancer. The trial seeks men diagnosed with non-metastatic prostate cancer, who have a specific type of cancer visible on MRI scans, and who plan to undergo cryoablation. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prostate cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that Barrigel is safe for use during prostate cryoablation?
Research has shown that Barrigel, a gel made from hyaluronic acid, is safe for use. The FDA has approved it for prostate radiation treatments, confirming its safety for these procedures. In previous studies, patients using Barrigel experienced less radiation exposure to the rectum, resulting in fewer bowel-related side effects.
Additionally, Barrigel caused fewer harmful effects in the first three months of use compared to a similar product, SpaceOAR. Patients experienced fewer negative health effects.
Overall, past studies have found Barrigel to be well-received, with no major safety issues reported. This makes it a promising option for those considering its use during prostate cryoablation procedures.12345Why are researchers excited about this trial?
Barrigel is unique because it acts as a protective barrier during prostate cancer treatments like cryoablation. Unlike traditional treatments such as surgery or radiation that can sometimes damage surrounding healthy tissues, Barrigel is an injectable gel that helps shield these areas from potential harm. Researchers are excited about this treatment because it not only enhances the precision of cryoablation but also aims to minimize side effects, potentially leading to better outcomes and improved quality of life for patients.
What evidence suggests that Barrigel is effective for prostate cancer cryoablation?
Studies have shown that Barrigel effectively reduces radiation exposure to the rectum. For prostate cancer patients receiving radiation, Barrigel can decrease unwanted radiation by up to 85%, leading to fewer side effects and improved quality of life. Research also indicates that Barrigel consistently creates space during treatment, protecting the rectum. In this trial, participants will undergo Barrigel placement before their image-guided prostate cryoablation. These findings suggest Barrigel can be a valuable tool in prostate cancer treatments.12456
Who Is on the Research Team?
Wei Phin Tan, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for men aged 40-95 with localized prostate cancer (confirmed by biopsy) that can be seen on MRI and treated with cryoablation. They must have a PSA under 20, no spread of cancer, and be willing to follow up after the procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo transperineal ultrasound-guided Barrigel placement and image-guided prostate cryoablation
Follow-up
Participants are monitored for safety and effectiveness, including assessment of SHIM and IPSS scores
What Are the Treatments Tested in This Trial?
Interventions
- Barrigel Injectable Gel
Trial Overview
The study tests if Barrigel, an injectable gel placed between the prostate and rectum, can safely protect the rectum during cryoablation treatment for prostate cancer. It looks at how well Barrigel holds up to freezing temperatures.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
Real-World Data on Barrigel and SpaceOAR Rectal Spacers ...
Real-world data show that SpaceOAR achieves better dosimetry than Barrigel likely due to larger insertion volumes. At similar insertion volumes, Barrigel ...
Barrigel Pivotal Trial: Safety and Clinical Outcomes
Barrigel pivotal trial data covering rectal dose reduction, GI toxicity, and symmetrical implant rates across balloon & hydrogel spacer trials for prostate ...
Feasibility and Outcomes of Perirectal Spacer Implantation ...
The purpose of this study was to evaluate feasibility of rectal spacer placement after prior pelvic radiation or other local treatments for prostate cancer.
News Details
Barrigel™ rectal spacer provides high quality rectal spacing, enabling low dose to the rectum during prostate cancer radiation therapy, ...
Utilization, Acute Complications, and Delays in Treatment ...
The trial demonstrated a >25% reduction in rectal volume receiving ≥70 gray (Gy) and significantly improved bowel quality of life at 3 years in patients with a ...
Barrigel Safety Data and FDA Clearance Information
FDA-cleared for prostate radiation, Barrigel has a defined safety profile. Review indications, contraindications, and side effects from the pivotal clinical ...
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