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

Launched by MARC DALL'ERA, MD · Dec 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods, focal cryotherapy and high-intensity focused ultrasound (HIFU), to treat men with localized prostate cancer. Focal cryotherapy works by freezing cancer cells, while HIFU uses focused sound waves to heat and destroy them. The goal is to find out which method is more effective for treating prostate cancer that hasn't spread beyond its original site.

To participate in this study, men aged 18 and older need to have localized prostate cancer that can be seen on an MRI and has a grade group of 1, 2, or 3. They should also be in good overall health and able to understand the study information and sign a consent form. Participants can expect to receive focused treatment for up to three visible cancer lesions and will need to attend regular study visits. It's important to note that individuals with prior prostate cancer treatment or certain health conditions may not be eligible to join the trial.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Ability to understand and willingness to sign an informed consent form
• • Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
• • Patients ≥ 18 years of age at time of consent
• • Life expectancy ≥ 5 years
• • Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
• Exclusion Criteria:
• • Nodal or distant metastases
• • Prior treatment for prostate cancer
• • Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
• • Known contraindications to general anesthesia
• • Uncorrectable coagulopathy
• • Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction
• • Any condition that would prohibit the understanding or rendering of informed consent
• • Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial