High-Intensity Focused Ultrasound in Treating Participants with Intermediate and High-risk Prostate Cancer

Inclusion Criteria

• Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside pathology will be re-reviewed at University of Southern California (USC) to verify diagnosis
• Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and have to be a surgical candidate for RP; this determination will be made by the patient in conjunction with their treating urologist and is current standard of practice
• Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist
• Ability to understand AND willingness to sign a written informed consent
• Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes

Exclusion Criteria

• Patients may not be receiving any other investigational agents or have received any definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder tumors [EBRT], Brachytherapy etc) prior
• Patients with known metastases would be excluded from this clinical trial
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinical significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptable
• Patients with rectal disease
• Patients who are unable to undergo MRI
• Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE)