Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067015
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2003-08-08
Brief Title:
Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT 864 GY Alone With IMRT to 756 GY Plus NeoadjuvantAdjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably Androgens can stimulate the growth of prostate cancer cells Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES
Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin
Compare the prostate-specific antigen relapse-free distant metastases-free and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the local control in patients treated with these regimens based on post-treatment sextant biopsies performed 4 years after study completion
OUTLINE This is a randomized study Patients are stratified according to prostate-specific antigen level Gleason score and clinical stage Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo high-dose intensity-modulated radiotherapy IMRT 4-5 times per week for 10 weeks a total of 48 treatments
Arm II Patients receive oral bicalutamide once daily for 185 weeks Three to seven days after the initiation of bicalutamide patients also receive goserelin subcutaneously monthly for 2 years Beginning after 10 weeks of hormonal therapy patients undergo concurrent high-dose IMRT 4-5 times per week for 85 weeks a total of 42 treatments Patients discontinue bicalutamide on or near the end of radiotherapy
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 months for 15 years after the completion of radiotherapy then 6 months later and then annually for 2 years
Patients are followed every 6-8 months for 4 years and then annually for 2 years
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 4-5 years
Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin
Compare the prostate-specific antigen relapse-free distant metastases-free and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the local control in patients treated with these regimens based on post-treatment sextant biopsies performed 4 years after study completion
OUTLINE This is a randomized study Patients are stratified according to prostate-specific antigen level Gleason score and clinical stage Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo high-dose intensity-modulated radiotherapy IMRT 4-5 times per week for 10 weeks a total of 48 treatments
Arm II Patients receive oral bicalutamide once daily for 185 weeks Three to seven days after the initiation of bicalutamide patients also receive goserelin subcutaneously monthly for 2 years Beginning after 10 weeks of hormonal therapy patients undergo concurrent high-dose IMRT 4-5 times per week for 85 weeks a total of 42 treatments Patients discontinue bicalutamide on or near the end of radiotherapy
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 months for 15 years after the completion of radiotherapy then 6 months later and then annually for 2 years
Patients are followed every 6-8 months for 4 years and then annually for 2 years
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 4-5 years
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 |
|---|---|---|---|
| MSKCC-03040 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |