Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514917
Status:
TERMINATED
Last Update Posted:
2013-11-03
First Post:
2007-08-02
Brief Title:
A Study of Androgen Deprivation With Leuprolide - Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen PSA
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open Label Multicenter Phase III 2-Arm Study of Androgen Deprivation With Leuprolide - Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision to discontinue the study not due to any safety or efficacy concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rising PSA
Brief Summary:
The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival PFS over the period of 18-month therapy and at least 18-month follow-up
The secondary objectives were
To assess cancer specific survival
To compare overall survival between the 2 treatment groups
To evaluate patient-reported outcomes including quality of life fatigue and sexual functioning as measured by 3 different assessments
The secondary objectives were
To assess cancer specific survival
To compare overall survival between the 2 treatment groups
To evaluate patient-reported outcomes including quality of life fatigue and sexual functioning as measured by 3 different assessments
Detailed Description:
The duration of the study per participant was to be at least 36 months of which the treatment period was 18 months for all participants followed by at least 18 months follow-up period
Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred disease progression unacceptable toxicity death participant refusal or treatment delay beyond the time frame that is permitted for each treatment
Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred disease progression unacceptable toxicity death participant refusal or treatment delay beyond the time frame that is permitted for each treatment
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 |
|---|---|---|---|
| 2007-000323-17 | EUDRACT_NUMBER | None | None |