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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 95 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BARRigel, a gel spacer placed between the prostate and rectum, during treatment that freezes prostate cancer. It checks whether the gel stays stable during freezing, is safe, and may protect the rectum. It is for men with cancer limited to the prostate or cancer that has come back.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 40–95.
  • A tissue sample confirms cancer limited to the prostate, with Grade Group 2 or higher (a cancer rating). Treatment for cancer that has come back may be allowed.
  • One cancer area is seen on a detailed MRI scan and can be treated by freezing part or all of the prostate.
  • PSA, a blood marker for prostate cancer, is below 20 ng/ml.
  • No cancer spread is seen on a PSMA PET/CT scan, if this scan is recommended by cancer care guidelines.
  • Able and willing to have freezing treatment through the skin between the scrotum and anus, with anesthesia.
  • Willing to attend follow-up visits, including PSA blood tests and scans.
  • The doctor decides that the back of the prostate needs freezing treatment.

Who can't join

  • Cancer has spread to other parts of the body.
  • Past radiation treatment to the prostate area.
  • A current infection in the rectum or urinary tract.
  • A known allergy to hyaluronic acid products, such as BARRigel, or contrast dyes used for scans.
  • Unable to tolerate an MRI scan.
  • Unable or unwilling to complete study follow-up.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

NY