Using focused ultrasound to treat localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of focal high intensity focused ultrasound (HIFU) therapy in men with localized radiorecurrent prostate cancer. It aims to assess both oncologic outcomes and changes in quality of life following the treatment. The study focuses on patients with clinically significant prostate cancer, defined as Gleason Grade Group 2 or above, and evaluates the therapy's impact compared to traditional whole gland approaches. The research is particularly relevant as there is limited prospective data on focal HIFU in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Tarik Benidir, MD — University of Florida
• Study coordinator: Lourdes Guallpa
• Email: lguallpa@ufl.edu
• Phone: 352-392-0510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.