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.
A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
PRIMARY OBJECTIVE:
- To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
- 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.
