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

Summary

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.

Eligibility

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.

Conditions3

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