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

April 8, 2025 updated by: David S Finley, MD, Kaiser Permanente

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90077
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIFU
Procedure: HIFU vs Cryoablation
HIFU vs cryoablation
Active Comparator: Cryoablation
Cryo
Procedure: HIFU vs Cryoablation
HIFU vs cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-field cancer persistence
Time Frame: 3 months
MRI and biopsy results
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUAss change from baseline
Time Frame: month 3, month 6, month 12, month 24
Change in urination over
month 3, month 6, month 12, month 24
IIEF change from baseline
Time Frame: month 3, month 6, month 12, month 24
Change in sexual function over time
month 3, month 6, month 12, month 24
Complications and satisfaction
Time Frame: month 3, month 6, month 12, month 24
month 3, month 6, month 12, month 24
PSA
Time Frame: month 3, month 6, month 12, month 24
PSA change over time
month 3, month 6, month 12, month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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