Prostate Cancer study: Barrigel Injectable Gel vs Cryoablation
Official title Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
ClinicalTrials.gov ID: NCT07567027
What this study is testing
- What it's testing
- The study will see if Barrigel can be safely used and possibly protect the rectum during prostate cryoablation, and will measure how it holds up to the cold temperatures.
- Who it's for
- Men with localized or recurrent prostate cancer who are scheduled for transperineal cryoablation.
- What's involved
- Participants will have a Barrigel spacer placed in the space next to the rectum before the cryoablation procedure, followed by standard monitoring and safety checks.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 95, men only
You may be able to join if
- 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)...
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.