Clinical trial NCT06929065: Randomized Trial of HIFU vs. Cryo for Prostate Cancer
Official title: Randomized Prospective Trial of Focal Therapy (HIFU vs Cryo) for Early Stage Unifocal Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Cancer Stage I
Prostate Cancer Stage II
High Intensity Focused Ultrasound
HIFU
Cryoablation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective open-label
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: In-field cancer persistence
timeFrame: 3 months
Secondary outcomes:
measure: AUAss change from baseline
timeFrame: month 3, month 6, month 12, month 24
measure: IIEF change from baseline
timeFrame: month 3, month 6, month 12, month 24
measure: Complications and satisfaction
timeFrame: month 3, month 6, month 12, month 24
measure: PSA
timeFrame: month 3, month 6, month 12, month 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
Study officials:
References:
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