Cryoablation, HIFU, High Intensity Focused Ultrasound, Prostate Cancer, Prostate Cancer Stage I, Prostate Cancer Stage II
Conditions
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.
Interventions
PROCEDUREHIFU vs Cryoablation
HIFU vs cryoablation
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized prospective open-label
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-field cancer persistence | 3 months | MRI and biopsy results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUAss change from baseline | month 3, month 6, month 12, month 24 | Change in urination over |
| IIEF change from baseline | month 3, month 6, month 12, month 24 | Change in sexual function over time |
| Complications and satisfaction | month 3, month 6, month 12, month 24 | — |
| PSA | month 3, month 6, month 12, month 24 | PSA change over time |
Countries
United States
Outcome results
None listed