Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002633
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4 N0 M0 Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2020-04
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 whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer
PURPOSE This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer
PURPOSE This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer
Detailed Description:
OBJECTIVES
Compare the overall survival disease specific survival and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation
Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease eg transurethral resections stent insertions nephrostomies and colostomies in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the sensitivity of the EORTC-QLQ-C303 and a trial-specific checklist PR17 with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens
OUTLINE This a randomized multicenter study Patients are stratified according to center initial PSA level less than 20 vs 20-50 vs greater than 50 ngmL method of node staging clinical no CT scan vs radiological CT scan negative vs surgical Gleason score less than 8 vs 8-10 prior hormonal therapy excluding orchiectomy yes vs no and choice of hormonal therapy bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone LHRH with antiandrogen Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive antiandrogen therapy comprising oral flutamide every 8 hours oral nilutamide every 8 hours for 1 month and then once daily or oral bicalutamide once daily Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously SC every 4 weeks short-acting formulation or every 3 months long-acting formulation leuprolide intramuscularly every 4 weeks short-acting formulation or every 3 months long-acting formulation or buserelin SC every 8 weeks or every 12 weeks Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery at the physicians discretion
Arm II Patients undergo total androgen ablation as in arm I Patients with node-negative dissection undergo radiotherapy 5 days a week for 65-7 weeks All other patients undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2-24 weeks
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on the last day of radiotherapy at 6 months and then every 6 months thereafter
Patients are followed at 1 2 and 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study within 75 years
Compare the overall survival disease specific survival and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation
Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease eg transurethral resections stent insertions nephrostomies and colostomies in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the sensitivity of the EORTC-QLQ-C303 and a trial-specific checklist PR17 with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens
OUTLINE This a randomized multicenter study Patients are stratified according to center initial PSA level less than 20 vs 20-50 vs greater than 50 ngmL method of node staging clinical no CT scan vs radiological CT scan negative vs surgical Gleason score less than 8 vs 8-10 prior hormonal therapy excluding orchiectomy yes vs no and choice of hormonal therapy bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone LHRH with antiandrogen Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive antiandrogen therapy comprising oral flutamide every 8 hours oral nilutamide every 8 hours for 1 month and then once daily or oral bicalutamide once daily Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously SC every 4 weeks short-acting formulation or every 3 months long-acting formulation leuprolide intramuscularly every 4 weeks short-acting formulation or every 3 months long-acting formulation or buserelin SC every 8 weeks or every 12 weeks Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery at the physicians discretion
Arm II Patients undergo total androgen ablation as in arm I Patients with node-negative dissection undergo radiotherapy 5 days a week for 65-7 weeks All other patients undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2-24 weeks
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on the last day of radiotherapy at 6 months and then every 6 months thereafter
Patients are followed at 1 2 and 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study within 75 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064065 | OTHER | PDQ | None |
| CAN-NCIC-PR3 | REGISTRY | None | None |
| ECOG-JPR03 | OTHER | None | None |
| MRC-PR07 | OTHER | None | None |
| SWOG-JPR3 | OTHER | None | None |
| EU-99013 | OTHER | None | None |
| NCI-T94-0110O | OTHER_GRANT | None | None |
| ISRCTN24991896 | REGISTRY | None | None |