Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486499
Status:
UNKNOWN
Last Update Posted:
2007-06-14
First Post:
2007-06-12
Brief Title:
I-125 Versus Pd-103 for Medium Risk Prostate Cancer
Sponsor:
VA Puget Sound Health Care System
Organization:
VA Puget Sound Health Care System
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
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:
hypothesis the shorter half-life of Pd-103 versus I-125 will increase the rate of tumor eradication
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma Gleason grade 7 to 9 andor PSA 10-20 ngml will be randomized to implantation with I-125 144 Gy versus Pd-103 124 Gy
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma Gleason grade 7 to 9 andor PSA 10-20 ngml will be randomized to implantation with I-125 144 Gy versus Pd-103 124 Gy
Detailed Description:
Objective The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125 will increase the rate of tumor eradication
Research plan
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma Gleason grade 7 to 9 andor PSA 10-20 ngml will be randomized to implantation with I-125 144 Gy versus Pd-103 124 Gy
Methodology
Randomization will be accomplished by the method of random permuted blocks
Cancer status will be monitored by yearly serial serum PSA 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
Primary endpoint Time to treatment failure Patients with serum PSA above 05 ngml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy
Research plan
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma Gleason grade 7 to 9 andor PSA 10-20 ngml will be randomized to implantation with I-125 144 Gy versus Pd-103 124 Gy
Methodology
Randomization will be accomplished by the method of random permuted blocks
Cancer status will be monitored by yearly serial serum PSA 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
Primary endpoint Time to treatment failure Patients with serum PSA above 05 ngml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy
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