This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
PRIMARY OBJECTIVE: I. To determine the efficacy of focal therapy for treatment of prostate cancer. SECONDARY OBJECTIVES: I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year. II. To assess safety. OUTLINE: Patients undergo focal cryotherapy or high intensity focused ultrasound on study. After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Undergo focal cryotherapy ablation
Undergo high intensity frequency ultrasound ablation
Ancillary studies
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGPathologic outcome on surveillance prostate biopsy
Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
Time frame: At year 1 and 3
Proportion of participants who go onto whole gland salvage treatment
Will be estimated using the Kaplan-Meier method.
Time frame: At 3 years
Salvage whole gland treatment free survival
Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.
Time frame: At 3 years
Urinary function
Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.
Time frame: At 1 year
Sexual function
Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.
Time frame: At 1 year
Quality of life
Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.
Time frame: At 1 year
Adverse events
Number of participants experiencing treatment-related AEs, classified by severity and grade.
Time frame: Up to end of treatment visit, approximately 7-14 days after treatment
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