Improving Cryoablation for Prostate Cancer with Barrigel Rectal Spacer
Official title: Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
Run by NYU Langone Health · NCT07567027 · Data updated 2026-11-12
This study tests whether Barrigel, a rectal spacer, can be safely used during prostate cryoablation to help protect surrounding tissues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 95 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07567027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 40–95 with biopsy-confirmed localized or recurrent prostate cancer, unifocal disease on mpMRI, PSA <20 ng/mL, no metastatic disease, and eligible for transperineal cryoablation under anesthesia.
✕Probably not a fit
Patients with metastatic disease, prior prostatic radiation, active infections, allergy to hyaluronic acid, or inability to tolerate MRI may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines the feasibility and safety of Barrigel as a rectal spacer during transperineal cryoablation for localized or recurrent prostate cancer. Participants are men 40–95 years old with biopsy-confirmed prostate cancer and suitable anatomy for focal or whole-gland cryoablation. The primary focus is on Barrigel’s thermal stability during the procedure and any protective effects observed. The study is conducted at NYU Langone Health and involves cryoablation with Barrigel injectable gel, with follow-up including PSA testing and imaging.
Why it matters
Potential benefit: If successful, Barrigel could reduce risks to nearby rectal tissue during cryoablation and improve treatment safety.
How similar studies have gone: Previous work in similar spacer strategies has shown potential protective effects in pelvic radiology and ablation contexts, but this specific approach in prostate cryoablation is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients aged 40-95 years. * Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included. * Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation. * Prostate-specific antigen (PSA) \< 20 ng/ml. * No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET/CT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines. * Eligible for and consenting to transperineal cryoablation under anesthesia. * Willingness to comply with post-procedure follow-up, including PSA testing and imaging. * Cryoablation which requires treatment of the posterior prostate as per clinician judgement. Exclusion Criteria: * Evidence of metastatic disease. * Prior radiation therapy to the area of the prostate. * Active rectal or urinary tract infection. * Known allergy to hyaluronic acid products or contrast agents. * Inability to tolerate MRI. * Inability or unwillingness to comply with study follow-up.
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Wei Phin Tan, MD — NYU Langone Health
- Study coordinator: Viola Sulollari
- Email: Viola.Sulollari@nyulangone.org
- Phone: (646) 825-6300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.