Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178354
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-12-09
Brief Title:
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
Sponsor:
Marc DallEra MD
Organization:
University of California Davis
Study Overview
Official Title:
A Pragmatic Phase 2 Study of Focal Ablation Focal Cryotherapy or High Intensity Frequency Ultrasound in Men With Clinically Localized Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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 clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer Focal cryotherapy kills tumor cells by freezing them High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of focal therapy for treatment of prostate cancer
SECONDARY OBJECTIVES
I Patient reported urinary sexual function and quality of life QOL at 1 year
II To assess safety
OUTLINE
Patients undergo focal cryotherapy or high intensity focused ultrasound on study
After completion of study treatment patients are followed up at 7-14 days and periodically for up to 3 years
I To determine the efficacy of focal therapy for treatment of prostate cancer
SECONDARY OBJECTIVES
I Patient reported urinary sexual function and quality of life QOL at 1 year
II To assess safety
OUTLINE
Patients undergo focal cryotherapy or high intensity focused ultrasound on study
After completion of study treatment patients are followed up at 7-14 days and periodically for up to 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09811 | REGISTRY | None | None |
| UCDCC306 | OTHER | None | None |
| P30CA093373 | NIH | University of California Davis Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA093373 |