Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 1:48 PM
Study NCT ID:
NCT00006359
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2000-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
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 (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
* Determine the safety of EBRT+BT in these patients.
* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder 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 (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
* Determine the safety of EBRT+BT in these patients.
* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |
| CALGB-99809 | None | None | View | |
| CDR0000068228 | REGISTRY | NCI Physician Data Query | View |