Randomized Trial of HIFU vs. Cryo for Prostate Cancer (KPFT)

Kaiser Permanente

Status: Completed

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

Treatments: Procedure: HIFU vs Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06929065

KPFT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

HIFU

Experimental group

Description:

HIFU

Treatment:

Procedure: HIFU vs Cryoablation

Cryoablation

Active Comparator group

Description:

Cryo

Treatment:

Procedure: HIFU vs Cryoablation