Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

Focal One high intensity focused ultrasound device

Tarik Benidir, MD

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.

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.

High Intensity Focused Ultrasound in Prostate Cancer

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

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.

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

Determine the complication rates (Clavien Dindo \>3) within the first 12 months. Complications include urinary tract infection, hematuria, urinary retention, stricture, bladder neck contracture, and incontinence.

Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 6 months after HIFU treatment.

Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 12 months after HIFU treatment.

Determine the change from baseline in International Index of Erectile Function questionnaire scores at 6 months after HIFU treatment.

Determine the change from baseline in International Index of Erectile Function questionnaire scores at 12 months after HIFU treatment.

Determine the time from HIFU to whole gland or systemic therapy

Determine the time from HIFU to androgen deprivation therapy onset

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
High Intensity Focused Ultrasound in Prostate Cancer	NCT06402357	Prostate Cancer	Focal One high ...	18 Years -	University of Florida
High Intensity Focused Ultrasound in Prostate Cancer	NCT06402357	Prostate Cancer	Focal One high ...	18 Years -	University of Florida

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