High Intensity Focused Ultrasound in Prostate Cancer
Salvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well focused high-intensity ultrasound (HIFU) treats prostate cancer that has come back after radiation and has not spread beyond the prostate. HIFU uses strong sound waves to treat a specific area. The study also compares patients' quality of life before and after treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men age 18 or older who have chosen HIFU for prostate cancer that came back after radiation, with or without hormone treatment.
- An ECOG activity score of 0–3, ranging from fully active to needing some help with self-care.
- An area of concern on an MRI or PSMA PET scan, which helps find prostate cancer.
- A tissue sample confirms cancer of grade group 2 or higher in or on the same side as the scan finding. The sample must be taken within 6 months of the scan.
- Grade group 1 cancer, a lower-grade cancer, on the opposite side of the prostate.
- A PSMA PET scan within 6 months of the tissue sample shows no cancer spread to distant parts of the body.
- No more than one active cancer. Another past or current cancer may be allowed if the study doctors agree it will not affect safety or study results.
- Sign a consent form and agree to follow all study procedures.
Who can't join
- Cannot safely have HIFU because of a latex allergy, a missing rectum, a past abnormal opening in the rectum, or major rectal surgery that prevents safe placement of the probe.
- Hormone treatment within 6 months of screening, or inflammatory bowel disease treated within the past 3 years.
- Scans show cancer growing beyond the prostate, in pelvic lymph nodes, or in distant body parts; or clinically important cancer is on both sides of the prostate.
- Radiation treatment seeds are still in place, or implanted markers or large calcium deposits would block successful HIFU treatment.
- Narrowing of the tube that carries urine was active in the past 6 months or needed more treatment than using a catheter from time to time.
- No past radiation treatment for prostate cancer, or no area of concern on an MRI or PET scan.
- Another health problem or test finding that the doctor believes could make treatment unsafe, raise the risk of problems, or make study results hard to judge.
- In prison or held against your will, including being required to stay for treatment of a mental or physical illness.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
FL
- University of Florida · Gainesville, FL 32608Lourdes Guallpa · Study contact · 352-392-0510 · lguallpa@ufl.eduTarik Benidir, MD · Principal investigatorMore trials in Gainesville