Status:
COMPLETED
Randomized Trial of HIFU vs. Cryo for Prostate Cancer
Lead Sponsor:
Kaiser Permanente
Conditions:
Prostate Cancer
Prostate Cancer Stage I
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
HIFU has been FDA approved and is widely utilized across the United States and Europe for the treatment of prostate cancer. Despite this, HIFU has not been offered within SCPMG until now due to growin...
Detailed Description
All men presenting with elevated prostate specific antigen (PSA) will be required to undergo an initial multiparametric MRI (MRI) and 14 core systematic biopsy. Decipher genomic testing will be run on...
Eligibility Criteria
Inclusion
- All men age 40 or older with Gleason group 1 or 2 prostate cancer involving a single or adjacent sextants
- PSA \< 10
- mpMRI without extracapsular extension or seminal vesicle invasion (non-focal MRI or organ confined)
- mpMRI which is either nonfocal or concordant with biopsy.
Exclusion
- Gleason group 3 or higher
- Multifocal disease
- mpMRI with ECE or SVI
- PSA \> 10
- Active anorectal disease
- Age \> 80
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06929065
Start Date
April 1 2023
End Date
February 1 2025
Last Update
April 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaiser Permanente
Los Angeles, California, United States, 90077