High Intensity Focused Ultrasound in Prostate Cancer

About This Trial

This study is testing a treatment called high-intensity focused ultrasound, which uses targeted sound waves to heat and destroy cancer cells, to see how well it works and how it affects everyday quality of life.
It is designed for men whose prostate cancer has returned in one specific area of the prostate after previous radiation therapy, but has not spread elsewhere in the body.
Before considering this trial, you should know that your cancer recurrence must be confirmed by scans and a biopsy, and you cannot have received hormone therapy within the past six months.
Additionally, you may not be eligible if you have certain rectal conditions or permanently implanted radiation seeds that prevent doctors from safely performing the procedure.

More Information

This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer.
This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing a treatment called high-intensity focused ultrasound, which uses targeted sound waves to heat and destroy cancer cells, to see how well it works and how it affects everyday quality of life.

Study Details

Start Date: May 14, 2025
Lead Sponsor: University of Florida

Full Eligibility Criteria

Inclusion Criteria

Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer
Males who are ≥ 18 years of age
Eastern Cooperative Oncology Group Performance Status of 0-3
A history of prostate cancer treated with radiation therapy +/- hormone therapy
MRI or prostate-specific membrane antigen (PSMA) PET region of interest (ROI)
Biopsy proven clinically significant prostate cancer (GG2 or above) recurrence within or ipsilateral to the ROI lesion (within 6 months of the MRI/PET).
Contralateral grade group 1 (GG1) prostate cancer disease to the ROI
PSMA PET negative for metastatic disease (within 6 months of the biopsy)
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 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 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.