NCT06402357

High Intensity Focused Ultrasound in Prostate Cancer

Salvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Focal therapy is increasingly popular due to its minimal side effect profile. Furthermore, HIFU has demonstrated favorable oncologic outcomes in well selected patients, including those with intermediate and high risk disease. In patients with radiorecurrent prostate cancer there remains a paucity of data on the value of focal therapy. Review of focal HIFU rather than whole gland HIFU is based on largely retrospective data and in an era where mpMRI and PSMA PET was not yet widely implemented thus not reflecting the current patient population seeking this care. In fact, and to the investigators' knowledge, only one study has prospectively evaluated focal HIFU therapy in radiorecurrent prostate cancer. Further evaluation into the value of focal HIFU in select men with localized radiorecurrent clinically significant prostate cancer is needed (clinically significant prostate cancer defined as GG2 or above. GG1 prostate cancer will not be considered clinically significant prostate cancer), both in terms of oncologic and functional outcomes as this patient population is increasing.

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-08-01
• Completion: 2029-08-01
• First posted: 2024-05-07
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study