Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
High Intensity Focused Ultrasound in Prostate Cancer
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Salvage Focal Therapy Via High Intensity Focused Ultrasound HIFU in Radiorecurrent Localized Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None