Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023686
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-09-13
Brief Title:
Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer
Detailed Description:
OBJECTIVES
Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy
Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens
Compare the side effects of these treatment regimens in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients undergo radical prostatectomy
Arm II Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1980 patients 990 per treatment arm will be accrued for this study within 55 years
Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy
Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens
Compare the side effects of these treatment regimens in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients undergo radical prostatectomy
Arm II Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1980 patients 990 per treatment arm will be accrued for this study within 55 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068851 | REGISTRY | NCI Physician Data Query | None |
| ACOSOG-Z0070 | None | None | None |