Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494546
Status:
COMPLETED
Last Update Posted:
2007-06-29
First Post:
2007-06-28
Brief Title:
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Sponsor:
VA Puget Sound Health Care System
Organization:
VA Puget Sound Health Care System
Study Overview
Official Title:
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Objective The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma Gleason grade 7 to 10 andor PSA 10 to 20 ngml will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost 90 Gy versus 105 Gy respectively
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma Gleason grade 7 to 10 andor PSA 10 to 20 ngml will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost 90 Gy versus 105 Gy respectively
Detailed Description:
Objective The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma Gleason grade 7 to 10 andor PSA 10 to 20 ngml will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost 90 Gy versus 105 Gy respectively
Methodology Patients will be randomized by the method of random permuted blocks
Cancer status will be monitored by serial serum PSA at 6 12 18 and 24 months and yearly thereafter Treatment-related morbidity will be monitored by personal interview using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1 3 6 12 and 24 months The primary endpoint will be based on serum PSA A value above 10 ngml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy
Findings 566 patients have been randomized and the study was closed due to slowing accrual A preliminary analysis shows similar morbidity between the treatment arms and nearly identical cancer control rates between randomization arms
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma Gleason grade 7 to 10 andor PSA 10 to 20 ngml will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost 90 Gy versus 105 Gy respectively
Methodology Patients will be randomized by the method of random permuted blocks
Cancer status will be monitored by serial serum PSA at 6 12 18 and 24 months and yearly thereafter Treatment-related morbidity will be monitored by personal interview using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1 3 6 12 and 24 months The primary endpoint will be based on serum PSA A value above 10 ngml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy
Findings 566 patients have been randomized and the study was closed due to slowing accrual A preliminary analysis shows similar morbidity between the treatment arms and nearly identical cancer control rates between randomization arms
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