RecruitingNot ApplicableNCT06178354

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


Sponsor

Marc Dall'Era, MD

Enrollment

100 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of focal ablation therapy — cryotherapy (freezing the tumor) and HIFU (high-intensity focused ultrasound that heats and destroys the tumor) — for men with localized, low-to-intermediate risk prostate cancer, to evaluate which approach better destroys the tumor while preserving urinary and sexual function. **You may be eligible if...** - You are male, 18 or older, with confirmed localized prostate cancer (Grade Group 1, 2, or 3) - Your cancer is visible on MRI as a lesion (up to 3 lesions allowed for focal treatment) - Your cancer has not spread to lymph nodes or other parts of the body - You have a life expectancy of at least 5 years and good performance status - You have not had prior treatment for prostate cancer **You may NOT be eligible if...** - Your prostate cancer has spread to lymph nodes or distant sites - You have already received treatment for prostate cancer (surgery, radiation, hormones) - You have significant heart disease or conditions that make anesthesia unsafe - You have blood clotting problems that cannot be corrected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECryosurgery

Undergo focal cryotherapy ablation

PROCEDUREHigh-Intensity Focused Ultrasound Ablation

Undergo high intensity frequency ultrasound ablation

OTHERSurvey Administration

Ancillary studies


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT06178354


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