Actively Recruiting
High Intensity Focused Ultrasound in Prostate Cancer
Led by University of Florida · Updated on 2025-06-15
25
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
E
EDAP-TMS Focal One
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
High Intensity Focused Ultrasound in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer
- Male aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status of 0-3
- History of prostate cancer treated with radiation therapy with or without hormone therapy
- MRI or prostate-specific membrane antigen (PSMA) PET region of interest (ROI)
- Biopsy confirmed clinically significant prostate cancer (grade group 2 or above) recurrence within or ipsilateral to the ROI lesion within 6 months of MRI/PET
- Contralateral grade group 1 prostate cancer disease to the ROI
- PSMA PET negative for metastatic disease within 6 months of biopsy
- No more than one active malignancy at enrollment (exceptions allowed if not interfering with study)
- Written informed consent and agreement to comply with study procedures
You will not qualify if you...
- Contraindications to high intensity focused ultrasound (latex allergy, absent rectum, prior rectal fistula, or significant rectal surgery preventing transrectal probe use)
- Hormone therapy within 6 months prior to screening (including listed oral and injection therapies)
- Active inflammatory bowel disease treated in last 3 years
- Evidence of recurrent disease at or beyond cT3 stage on imaging
- Bilateral clinically significant prostate cancer
- Presence of brachytherapy seeds still implanted
- Presence of fiduciary markers obstructing lesion treatment
- Large calcification limiting quality HIFU treatment
- Active urethral stricture disease in last 6 months requiring more than clean intermittent catheterization
- No prior radiation therapy for prostate cancer
- No region of interest identified on MRI or PET
- Metastatic or locally advanced disease (pelvic lymph node involvement or T4 disease) on PSMA PET
- Any other disease or condition posing high risk for treatment complications or affecting study interpretation as judged by physician
- Prisoners or involuntarily incarcerated individuals or those compulsorily detained for psychiatric or physical illness
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
P
Priya Gurjar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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