Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03814252
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2019-01-22
Brief Title:
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
PRO-TULSA-PC
Brief Summary:
Magnetic resonance imaging MRI has improved detection of clinically significant prostate cancer PCa MRI-guided transurethral ultrasound ablation MRI-TULSA system incorporates precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted treatment of PCa Lesion-based treatment strategy spares surrounding healthy tissues from injury which may improve the outcome of genitourinary function This study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA
Detailed Description:
Improving diagnostic methods and screening of men with prostate specific antigen PSA has led to earlier detection of prostate cancer PCa with more favorable disease characteristics To decrease overtreatment low risk cases are increasingly treated with active surveillance nevertheless some of them progress requiring interventions Intermediate- and high-risk cases need active treatments to improve survival However despite desirable local control the standard therapies including radical prostatectomy and radiation therapy carry a risk of treatment related adverse effects to genitourinary and bowel functions There is an eminent need for efficient PCa therapies with minimal effect on genitourinary function and quality of life To date most studied mini-invasive technologies have used extremities of temperatures to treat PCa including high intensity focused ultrasound and cryoablation
Magnetic resonance imaging MRI has improved PCa diagnosis Novel MRI techniques enable localization and visualization of clinically significant PCa Further MRI can be used for guidance of targeted biopsy from suspicious lesion enhancing detection of clinically significant PCa and pinpointing a target for image guided therapies Also increased use of MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet need for image guided therapies
MRI guided transurethral ultrasound ablation MRI-TULSA - treatment system offers treatment strategy incorporating precise diagnosis and targeted therapy It has been evaluated for whole-gland ablation of localized PCa Further lesion-targeted MRI-TULSA has been proved to be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant PCa in our phase 1 treat-and-3-week-resect study not published yet This current study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA
Magnetic resonance imaging MRI has improved PCa diagnosis Novel MRI techniques enable localization and visualization of clinically significant PCa Further MRI can be used for guidance of targeted biopsy from suspicious lesion enhancing detection of clinically significant PCa and pinpointing a target for image guided therapies Also increased use of MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet need for image guided therapies
MRI guided transurethral ultrasound ablation MRI-TULSA - treatment system offers treatment strategy incorporating precise diagnosis and targeted therapy It has been evaluated for whole-gland ablation of localized PCa Further lesion-targeted MRI-TULSA has been proved to be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant PCa in our phase 1 treat-and-3-week-resect study not published yet This current study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA
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?:
None
Is an FDA AA801 Violation?:
None