High Intensity Focused Ultrasound in Prostate Cancer

NCT06402357 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: UF-GU-009IRB202401126
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; high intensity focused ultrasound; focal therapy

Outcome Measures

Primary Outcomes (1)

• In-field failure-free survival

  Evaluate the in-field failure-free survival (IFFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. IFFFS is defined as the absence of biopsy proven clinically significant prostate cancer in the treated zone.

  12 months

Secondary Outcomes (8)

• Local failure-free survival

  12 months

• Complication rates

  12 months

• Change in quality of life metrics

  6 months

• Change in quality of life metrics

  12 months

• Change in quality of life metrics

  6 months

Study Arms (1)

High Intensity Focused Ultrasound

EXPERIMENTAL

Device: Focal One high intensity focused ultrasound device

Interventions

Focal One high intensity focused ultrasound device DEVICE

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

High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• EDAP-TMS Focal One: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tarik Benidir, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya Gurjar

CONTACT

352-273-6772; PMO@cancer.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)