Actively Recruiting
A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
Led by Marc Dall'Era, MD · Updated on 2024-12-16
100
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
M
Marc Dall'Era, MD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies men with localized prostate cancer to compare two types of focal ablation treatments: focal cryotherapy and high intensity focused ultrasound. The goal is to see how well these treatments work to destroy tumor cells by freezing or heating them, and to assess patient urinary and sexual function, quality of life, and safety after treatment. Participants receive either focal cryotherapy or high intensity focused ultrasound to target prostate tumors. After treatment, follow-up visits occur at 7 to 14 days, then periodically for up to three years to monitor outcomes and any side effects. During the study, patients undergo prostate biopsies at one and three years to check the treatment effect. Researchers also track how many need additional whole gland salvage treatment and measure urinary and sexual function, quality of life at one year, and adverse events shortly after treatment. The total follow-up lasts about three years.
CONDITIONS
Brief Title
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Clinically localized grade group 1, 2, or 3 prostate cancer with up to 3 unilateral MRI-visible lesions
- ECOG performance status of 0 or 1 (Karnofsky score 70% or higher)
- Male patients aged 18 years or older at consent
- Life expectancy of 5 years or more
- Willingness to follow study visit schedule and protocol requirements
You will not qualify if you...
- Presence of nodal or distant metastases
- Prior prostate cancer treatment
- Cancer treatment such as radiation, hormonal therapy, or surgery within 6 months before focal therapy in this study
- Known contraindications to general anesthesia
- Uncorrectable bleeding disorders
- Significant active heart disease within the past 6 months including NYHA class 4 heart failure, unstable angina, or recent heart attack
- Any condition preventing informed consent
- Any condition that may interfere with safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 7 to 14 days
Participants undergo focal cryotherapy or high intensity focused ultrasound ablation for prostate cancer.
1 treatment visit (in-person)
Duration - Up to 3 years
Participants are followed up periodically to monitor safety, urinary and sexual function, quality of life, and cancer status for up to 3 years after treatment.
Follow-up visits at 7 to 14 days post-treatment and periodic visits up to 3 years
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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