NCT06929065

Randomized Trial of HIFU vs. Cryo for Prostate Cancer

Randomized Prospective Trial of Focal Therapy (HIFU vs Cryo) for Early Stage Unifocal Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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 growing patient demand. We have offered cryoablation. This pilot study will determine the efficacy of HIFU vs. cryoablation focal therapy for early stage prostate cancer within SCPMG. We hope to elucidate whether outcomes are similar between the two modalities.

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 all prostate cancer specimens. 48 men with with unifocal low-intermediate risk prostate cancer (clinical stage T1-T2, Gleason group 1-2) prostate cancer will be offered focal therapy vs. conventional therapy (surgery or radiation) via shared decision making. Those who elect focal therapy (FT) will be enrolled and randomized 1:1 to HIFU or cryoablation. Men with negative biopsy, multifocal disease, or unfavorable intermediate risk or higher disease will be excluded and offered standard therapy (surgery or radiation). Following treatment, mpMRI and biopsy will be performed at 3mo. Baseline, 3mo, 6mo and 12mo post-treatment PSA will be obtained. In field and out of field cancer recurrence will be determined. Baseline and 3mo American Urologic Association Symptom Score (AUAss) and International Index of Erectile Function (IIEF) will be recorded as well as any treatment related side-effects or complications. SpaceOAR hydrogel will be utilized for all posterior lesions.

Conditions

• Prostate Cancer
• Prostate Cancer Stage I
• Prostate Cancer Stage II
• High Intensity Focused Ultrasound
• HIFU
• Cryoablation

Interventions

Type	Name	Description
PROCEDURE	HIFU vs Cryoablation	HIFU vs cryoablation

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States