Prostate Cancer (Diagnosis), Transperineal Cryoablation
Conditions
Keywords
cryoablation, prostate, Barrigel
Brief 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.
Interventions
DEVICEBarrigel Injectable Gel
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
PROCEDURECryoablation
Minimally invasive treatment for both localized and recurrent prostate cancer.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles) | End of procedure (up to 4 hours) | Barrigel freeze will be defined as a measured temperature ≤ 0°C within or immediately adjacent to the gel, or ultrasound evidence of ice formation within the gel volume. Thermal stability will therefore be expressed as the percentage of procedures in which Barrigel resists freezing under standard cryoablation conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Barrigel-related complications post-procedure | Visit 3 (6 months post-procedure) | — |
| Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural | Visit 1 (Baseline), Visit 3 (6 months post-procedure) | — |
| Change from baseline in International Prostate Symptom Score (IPSS) | Visit 1 (Baseline), Visit 2 (3 months post-procedure) | The International Prostate Symptom Score (IPSS) is a validated, 8-question self-assessment tool (7 symptom questions + 1 quality of life question) used to evaluate the severity of lower urinary tract symptoms (LUTS). Scores range from 0-35: Mild (0-7), Moderate (8-19), and Severe (20-35). |
| Change from baseline in Sexhual Health Inventory for Men (SHIM) score | Visit 1 (Baseline), Visit 2 (3 months post-procedure) | The SHIM Questionnaire (also known as the IIEF-5) is an abridged and slightly modified 5-item version of the 15-item International Index of Erectile Function (IIEF) designed for easy use by clinicians to diagnose the presence and severity of erectile dysfunction (ED) in clinical settings. Scores range from 5-25: Severe ED (5-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), and No ED (22-25) |
| Volume of Barrigel injected (mL) | After administration (up to 1 hour) | — |
| Rectal wall separation achieved (mm) | After administration (up to 1 hour) | — |
Countries
United States
Contacts
CONTACTViola Sulollari
CONTACTWei Phin Tan, MD
PRINCIPAL_INVESTIGATORWei Phin Tan, MD
NYU Langone Health
Outcome results
None listed