Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489060
Status:
COMPLETED
Last Update Posted:
2008-07-17
First Post:
2007-06-20
Brief Title:
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2008-07
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:
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer
Detailed Description:
Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy median dose 68 Gy All patients received neoadjuvant antiandrogen therapy The primary endpoint was disease progression at 36 months based on a trifecta definition of failure a radiological evidence of metastatic disease or b initiation of further antineoplastic therapy or c biochemical failure Two definitions of biochemical failure were used 1 rising PSA with a final value 10 ngmL and 2 rise above PSA nadir 2 ngmL Secondary endpoints were overall survival disease-specific survival and positive prostate biopsy at 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None