This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.
Focal therapy is increasingly popular due to its minimal side effect profile. Furthermore, HIFU has demonstrated favorable oncologic outcomes in well selected patients, including those with intermediate and high risk disease. In patients with radiorecurrent prostate cancer there remains a paucity of data on the value of focal therapy. Review of focal HIFU rather than whole gland HIFU is based on largely retrospective data and in an era where mpMRI and PSMA PET was not yet widely implemented thus not reflecting the current patient population seeking this care. In fact, and to the investigators' knowledge, only one study has prospectively evaluated focal HIFU therapy in radiorecurrent prostate cancer. Further evaluation into the value of focal HIFU in select men with localized radiorecurrent clinically significant prostate cancer is needed (clinically significant prostate cancer defined as GG2 or above. GG1 prostate cancer will not be considered clinically significant prostate cancer), both in terms of oncologic and functional outcomes as this patient population is increasing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Participants will be treated with one session of high intensity focused ultrasound using the Focal One device.
University of Florida
Gainesville, Florida, United States
RECRUITINGIn-field failure-free survival
Evaluate the in-field failure-free survival (IFFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. IFFFS is defined as the absence of biopsy proven clinically significant prostate cancer in the treated zone.
Time frame: 12 months
Local failure-free survival
Evaluate the local failure-free survival (LFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. LFFS is defined as the absence of biopsy proven clinically significant prostate cancer both in and out of the treated zone.
Time frame: 12 months
Complication rates
Determine the complication rates (Clavien Dindo \>3) within the first 12 months. Complications include urinary tract infection, hematuria, urinary retention, stricture, bladder neck contracture, and incontinence.
Time frame: 12 months
Change in quality of life metrics
Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 6 months after HIFU treatment.
Time frame: 6 months
Change in quality of life metrics
Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 12 months after HIFU treatment.
Time frame: 12 months
Change in quality of life metrics
Determine the change from baseline in International Index of Erectile Function questionnaire scores at 6 months after HIFU treatment.
Time frame: 6 months
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Change in quality of life metrics
Determine the change from baseline in International Index of Erectile Function questionnaire scores at 12 months after HIFU treatment.
Time frame: 12 months
Time from HIFU to whole gland or systemic therapy
Determine the time from HIFU to whole gland or systemic therapy
Time frame: 3 years
Time from HIFU to androgen deprivation therapy onset
Determine the time from HIFU to androgen deprivation therapy onset
Time frame: 3 years