Recruiting
Phase 2

High Intensity Focused Ultrasound

Sponsor:

University of Florida

Code:

NCT06402357

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focal One high intensity focused ultrasound device

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT06402357

Start date

May 14, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High Intensity Focused Ultrasound

Interventions

Focal One high intensity focused ultrasound device

Participants will be treated with one session of high intensity focused ultrasound using the Focal One device.

Primary outcome measure

  • In-field failure-free survival [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Lourdes Guallpa

352-392-0510lguallpa@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Lourdes Guallpa

352-392-0510lguallpa@ufl.edu

Principal Investigator:

Tarik Benidir, MD

More Information

Sponsor

University of Florida

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • prostate cancer
  • high intensity focused ultrasound
  • focal therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-08.