NCT06178354

Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Marc Dall'Era, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Localized Prostate Carcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Cryosurgery	Undergo focal cryotherapy ablation
PROCEDURE	High-Intensity Focused Ultrasound Ablation	Undergo high intensity frequency ultrasound ablation
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2023-11-09
• Primary completion: 2028-11-01
• Completion: 2029-06-01
• First posted: 2023-12-21
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States