Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023829
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2001-09-13
Brief Title:
Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-11
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 Androgens can stimulate the growth of prostate cancer cells Drugs such as flutamide or bicalutamide may stop the adrenal glands from producing androgens Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer Hormone therapy alone group closed as of 1292002
PURPOSE Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare the overall survival disease-free survival freedom from distant metastases and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone
Compare the qualitative and quantitative toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to seminal vesicle invasion yes vs no preoperative PSA 10 ngmL or less vs greater than 10 ngmL Gleason score 2-6 vs 7 vs 8-10 positive surgical margins yes vs no and neoadjuvant hormonal therapy yes vs no Patients are randomized to 1 of 3 treatment arms Arm III closed to accrual as of 1292002
Arm I Patients undergo radiotherapy once daily 5 days a week for 7 weeks Beginning the first day of radiotherapy patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month
Arm II Patients undergo radiotherapy as in arm I
Arm III Closed to accrual as of 1292002Patients receive hormonal therapy 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 1398 patients 699 per treatment arm will be accrued for this study within 5 years Arm III closed to accrual as of 1292002
Compare the overall survival disease-free survival freedom from distant metastases and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone
Compare the qualitative and quantitative toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to seminal vesicle invasion yes vs no preoperative PSA 10 ngmL or less vs greater than 10 ngmL Gleason score 2-6 vs 7 vs 8-10 positive surgical margins yes vs no and neoadjuvant hormonal therapy yes vs no Patients are randomized to 1 of 3 treatment arms Arm III closed to accrual as of 1292002
Arm I Patients undergo radiotherapy once daily 5 days a week for 7 weeks Beginning the first day of radiotherapy patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month
Arm II Patients undergo radiotherapy as in arm I
Arm III Closed to accrual as of 1292002Patients receive hormonal therapy 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 1398 patients 699 per treatment arm will be accrued for this study within 5 years Arm III closed to accrual as of 1292002
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 |
|---|---|---|---|
| CAN-NCIC-PR9 | None | None | None |
| CDR0000068868 | None | None | None |