High Intensity Focused Ultrasound in Prostate Cancer

Exclusion Criteria

• •Contraindication to high intensity focused ultrasound (latex allergy, absent rectum, prior rectal fistula or significant rectal surgery making insertion of transrectal probe non-feasible or dangerous.)
• •Hormone therapy within 6 months of the screening period (Hormone therapy includes oral (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex) injections (firmagon, Lupron))
• •History of Inflammatory Bowel Disease actively treated in last 3 years
• •Evidence of ≥ cT3 recurrent disease on imaging
• •Bilateral clinically significant prostate cancer
• •Presence of brachytherapy seeds still implanted
• •Presence of fiduciary markers which directly impede the successful treatment of the lesion of concern, as decided upon by the surgeon upon review of imaging
• •Large Calcification on CT or transrectal ultrasound which, as per the review of the surgeon, limits or hinders a quality high intensity focused ultrasound to the region of interest
• •Urethral stricture disease that has been active over the last 6 months or required further treatment than clean intermittent catheterization
• •No prior radiation therapy for prostate cancer
• •Subjects without a ROI on MRI or PET
• •Metastatic disease or locally advanced disease (defined by pelvic lymph node involvement or T4 disease) on PSMA PET
• •History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.