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.
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
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
Single group
Cryosurgery
Procedure/SurgeryUndergo focal cryotherapy ablation
High-Intensity Focused Ultrasound Ablation
Procedure/SurgeryUndergo high intensity frequency ultrasound ablation
Survey Administration
Other interventionAncillary studies
Pathologic outcome on surveillance prostate biopsy
Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
Proportion of participants who go onto whole gland salvage treatment
Will be estimated using the Kaplan-Meier method.
Salvage whole gland treatment free survival
Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.
Urinary function
Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.
Sexual function
Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.
Quality of life
Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.
Adverse events
Number of participants experiencing treatment-related AEs, classified by severity and grade.
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University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
