A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
Summary
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.
Detailed description
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.
Arms & interventions
- ProcedureCryosurgery
Undergo focal cryotherapy ablation
- ProcedureHigh-Intensity Focused Ultrasound Ablation
Undergo high intensity frequency ultrasound ablation
- OtherSurvey Administration
Ancillary studies
Outcome measures
Primary
Pathologic 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
Secondary
Urinary function
Time frame: At 1 year
Sexual function
Time frame: At 1 year
Quality of life
Time frame: At 1 year
Adverse events
Time frame: Up to end of treatment visit, approximately 7-14 days after treatment
Eligibility criteria
Study locations (1)
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817