High Intensity Focused Ultrasound for the Treatment of Radiorecurrent Localized Prostate Cancer

Inclusion Criteria

• Patient has elected to undergo focal HIFU therapy for radiorecurrent prostate cancer
• Males who are ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• A history of prostate cancer (PCa) treated with radiation therapy +/- hormone therapy
• MRI or PSMA PET region of interest (ROI)
• Biopsy proven prostate cancer (csPCa) recurrence within or ipsilateral to the ROI lesion (within 6 months of the MRI/PET)
• PSMA PET negative for metastatic disease (within 6 months of HIFU)
• Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the principal investigator (PI)] may be included)
• Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures

Exclusion Criteria

• Contraindication to HIFU (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 csPCa
• 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 computed tomography (CT) or transrectal ultrasound (TRUS) which, as per the review of the surgeon, limits or hinders a quality HIFU 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 (RT) for PCa
• 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