Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138008
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-08-29
Brief Title:
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
Sponsor:
Haruhiko Fukuda
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy JCOG0401
Status:
COMPLETED
Status Verified Date:
2016-09
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:
The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy
Detailed Description:
A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer T1-2 N0M0 are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone Urologic Oncology Study Group UOSG in the JCOG composed of 36 specialized institutions will recruit 200 patients The primary endpoint is time to treatment failure TTF of bicalutamide and secondary endpoints are TTF of protocol treatment progression free survival overall survival adverse events and quality of life QOL The Clinical Trial Review Committee of the Japan Clinical Oncology Group JCOG approved the protocol on April 13 2004 and the study was activated on May 17 2004
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 |
|---|---|---|---|
| C000000026 | REGISTRY | UMIN-CTR | None |