Randomized Trial of HIFU vs. Cryo for Prostate Cancer

NCT ID: NCT06929065

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU

HIFU

Group Type: EXPERIMENTAL

HIFU vs Cryoablation

Intervention Type: PROCEDURE

HIFU vs cryoablation

Cryoablation

Cryo

Group Type: ACTIVE_COMPARATOR

HIFU vs Cryoablation

Intervention Type: PROCEDURE

HIFU vs cryoablation

Interventions

HIFU vs Cryoablation

HIFU vs cryoablation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

David S Finley, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaiser Permanente

Los Angeles, California, United States

Countries

United States

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Other Identifiers

KPFT

Identifier Type: -

Identifier Source: org_study_id