Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006359
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2000-10-04
Brief Title:
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy EBRT With Brachytherapy BT Boost for Intermediate Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 leuprolide goserelin flutamide or bicalutamide may stop the adrenal glands from making androgens Radiation therapy uses high-energy x-rays to damage tumor cells Giving these drugs together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer
PURPOSE This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy EBRTBT in patients with intermediate-risk localized prostate cancer
Determine the safety of EBRTBT in these patients
Determine in a preliminary manner the efficacy of EBRTBT in terms of rate of local recurrence at 5 years time to prostate-specific antigen failure and time to first rectalbladder injury in these patients
OUTLINE Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks
Within 4 weeks after initiation of androgen-suppression therapy patients undergo external-beam radiotherapy EBRT once daily 5 days a week for 5 weeks At 2-4 weeks after completion of EBRT patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy EBRTBT in patients with intermediate-risk localized prostate cancer
Determine the safety of EBRTBT in these patients
Determine in a preliminary manner the efficacy of EBRTBT in terms of rate of local recurrence at 5 years time to prostate-specific antigen failure and time to first rectalbladder injury in these patients
OUTLINE Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks
Within 4 weeks after initiation of androgen-suppression therapy patients undergo external-beam radiotherapy EBRT once daily 5 days a week for 5 weeks At 2-4 weeks after completion of EBRT patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068228 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-99809 | None | None | None |