Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002597
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE
Status:
COMPLETED
Status Verified Date:
2018-05
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 Radiation therapy RT uses high-energy x-rays to damage tumor cells Androgens can stimulate the growth of prostate cancer cells Hormone therapy using flutamide goserelin and leuprolide may fight prostate cancer by reducing the production of androgens It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES Primary To evaluate whether a combination of Zoladex and flutamide used as cytoreductive agents prior to and during definitive radiation therapy improves overall survival over radiation therapy alone in locally confined carcinomas of the prostate Secondary To compare the rates of disease-specific survival clinical relapse local progression andor distant failure freedom from prostate-specific antigen PSA failure freedom from second clinical relapse freedom from second PSA relapse and disease-free survival To compare the prostate re-biopsy at two years To measure the effect on sexual function
OUTLINE This is a randomized multicenter study Patients were stratified by PSA level less than 4 vs 4-20 tumor differentiation well vs moderate vs poor nodal status N0 nodes evaluated by surgical sampling vs NX nodes evaluated negative by imaging methods only and participating center Patients are randomized to one of two treatment arms Arm I Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks or once as a time release injection intramuscular leuprolide may be substituted for goserelin beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks Arm II Patients undergo radiotherapy only as in arm I Patients are followed every 3 months for the remainder of the first year every 4 months for the second year every 6 months for the third through fifth years and then annually thereafter
PROJECTED ACCRUAL A total of 1980 patients within 5 years
OUTLINE This is a randomized multicenter study Patients were stratified by PSA level less than 4 vs 4-20 tumor differentiation well vs moderate vs poor nodal status N0 nodes evaluated by surgical sampling vs NX nodes evaluated negative by imaging methods only and participating center Patients are randomized to one of two treatment arms Arm I Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks or once as a time release injection intramuscular leuprolide may be substituted for goserelin beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks Arm II Patients undergo radiotherapy only as in arm I Patients are followed every 3 months for the remainder of the first year every 4 months for the second year every 6 months for the third through fifth years and then annually thereafter
PROJECTED ACCRUAL A total of 1980 patients within 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 |
|---|---|---|---|
| CDR0000063821 | None | None | None |