Randomized Trial of HIFU vs. Cryo for Prostate Cancer | NCT06929065

Studies
Randomized Trial of HIFU vs. Cryo for Prostate Cancer

NCT06929065

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Apr 15, 2025Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

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

Interventions

HIFU vs Cryoablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Feb 1, 2025Actual

Completion Date

Feb 1, 2025Actual

First Submitted Date

Nov 16, 2022

First Submission Date that Met QC Criteria

Apr 8, 2025

First Posted Date

Apr 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2025

Last Update Posted Date

Apr 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIFU	Experimental	HIFU	Procedure: HIFU vs Cryoablation
Cryoablation	Active Comparator	Cryo	Procedure: HIFU vs Cryoablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIFU vs Cryoablation	Procedure	HIFU vs cryoablation	Cryoablation HIFU

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
AUAss change from baseline	Change in urination over	month 3, month 6, month 12, month 24
IIEF change from baseline	Change in sexual function over time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Gleason group 3 or higher
Multifocal disease
mpMRI with ECE or SVI
PSA > 10
Active anorectal disease
Age > 80

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente		Los Angeles	California	90077	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34003610	Result	Bakavicius A, Marra G, Macek P, Robertson C, Abreu AL, George AK, Malavaud B, Coloby P, Rischmann P, Moschini M, Rastinehad AR, Sidana A, Stabile A, Tourinho-Barbosa R, de la Rosette J, Ahmed H, Polascik T, Cathelineau X, Sanchez-Salas R. Available evidence on HIFU for focal treatment of prostate cancer: a systematic review. Int Braz J Urol. 2022 Mar-Apr;48(2):263-274. doi: 10.1590/S1677-5538.IBJU.2021.0091.
29960750

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms