Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104715
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2005-03-03
Brief Title:
Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
Status:
COMPLETED
Status Verified Date:
2021-02
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 Androgens can cause the growth of prostate cancer cells Drugs such as goserelin may stop the adrenal glands from making androgens Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer
Detailed Description:
OBJECTIVES
Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone
Compare 24-month progression-free survival biological progression andor clinical progression in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare costs of these regimens for these patients
Compare the tolerability of these regimens in these patients
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive hormonal therapy comprising 1 of the following goserelin alone OR goserelin and antiandrogen therapy OR surgical castration Hormonal therapy continues until the development of hormone resistance Within 2 months after initiation of hormonal therapy patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive hormonal therapy as in arm I Quality of life is assessed
PROJECTED ACCRUAL A total of 378 patients will be accrued for this study
Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone
Compare 24-month progression-free survival biological progression andor clinical progression in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare costs of these regimens for these patients
Compare the tolerability of these regimens in these patients
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive hormonal therapy comprising 1 of the following goserelin alone OR goserelin and antiandrogen therapy OR surgical castration Hormonal therapy continues until the development of hormone resistance Within 2 months after initiation of hormonal therapy patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive hormonal therapy as in arm I Quality of life is assessed
PROJECTED ACCRUAL A total of 378 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20505 | None | None | None |
| FRE-FNCLCC-GETUG-150403 | None | None | None |