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Recruiting Phase 2 NCT06402357

High Intensity Focused Ultrasound in Prostate Cancer

Trial Parameters

Condition Prostate Cancer
Sponsor University of Florida
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 25
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2025-05-14
Completion 2027-08
Interventions
Focal One high intensity focused ultrasound device

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.

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 trea

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