Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005044
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2000-04-06
Brief Title:
Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression TAS and Radiation Therapy RT in Intermediate-Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2022-05
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 Hormones can stimulate the growth of prostate cancer cells Hormone therapy may fight prostate cancer by reducing the production of androgens Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of moderate-duration 28 weeks neoadjuvant total androgen suppression TAS and radiotherapy RT with short-duration 8 weeks neoadjuvant TAS and RT as related to disease-specific survival in patients with intermediate-risk adenocarcinoma of the prostate
Compare these regimens in terms of overall survival disease-free survival time to local tumor progression or distant failure time to first biochemical failure hormone-refractory state and treatment-induced morbidity in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to prostate-specific antigen level no greater than 10 ngmL vs greater than 10 but no greater than 20 ngmL vs greater than 20 ngmL tumor stage T1b-2 vs T3-4 Gleason score 2-4 vs 5-6 vs 7-10 and prior hormonal therapy yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy A luteinizing hormone-releasing hormone LHRH agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks Beginning with week 9 patients undergo radiotherapy 5 days a week for 8 weeks
Arm II Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks Beginning with week 29 patients undergo radiotherapy as in arm I
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 1540 patients 770 per treatment arm will be accrued for this study within 4 years
Compare the efficacy of moderate-duration 28 weeks neoadjuvant total androgen suppression TAS and radiotherapy RT with short-duration 8 weeks neoadjuvant TAS and RT as related to disease-specific survival in patients with intermediate-risk adenocarcinoma of the prostate
Compare these regimens in terms of overall survival disease-free survival time to local tumor progression or distant failure time to first biochemical failure hormone-refractory state and treatment-induced morbidity in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to prostate-specific antigen level no greater than 10 ngmL vs greater than 10 but no greater than 20 ngmL vs greater than 20 ngmL tumor stage T1b-2 vs T3-4 Gleason score 2-4 vs 5-6 vs 7-10 and prior hormonal therapy yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy A luteinizing hormone-releasing hormone LHRH agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks Beginning with week 9 patients undergo radiotherapy 5 days a week for 8 weeks
Arm II Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks Beginning with week 29 patients undergo radiotherapy as in arm I
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 1540 patients 770 per treatment arm will be accrued for this study within 4 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 |
|---|---|---|---|
| CDR0000067635 | None | None | None |