Randomized Trial of HIFU vs. Cryo for Prostate Cancer

Not Applicable

Completed

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

• Registration Number: NCT06929065
• Lead Sponsor: Kaiser Permanente

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 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.

Study Timeline

• Study First Submitted: 2022-11-16
• Study Start: 2023-04-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. All men age 40 or older with Gleason group 1 or 2 prostate cancer involving a single or adjacent sextants
2. PSA < 10
3. mpMRI without extracapsular extension or seminal vesicle invasion (non-focal MRI or organ confined)
4. mpMRI which is either nonfocal or concordant with biopsy.

Exclusion Criteria

1. Gleason group 3 or higher
2. Multifocal disease
3. mpMRI with ECE or SVI
4. PSA > 10
5. Active anorectal disease
6. Age > 80

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In-field cancer persistence	3 months	MRI and biopsy results

Secondary Outcome Measures

Name	Time	Method
AUAss change from baseline	month 3, month 6, month 12, month 24	Change in urination over
IIEF change from baseline	month 3, month 6, month 12, month 24	Change in sexual function over time
Complications and satisfaction	month 3, month 6, month 12, month 24
PSA	month 3, month 6, month 12, month 24	PSA change over time

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Los Angeles, California, United States