Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)

Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial

The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.

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.