Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014586
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2001-04-10
Brief Title:
Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G Any Gleason NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Testosterone can stimulate the growth of cancer cells Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone It is not yet known which hormone therapy regimen is most effective for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer
Detailed Description:
OBJECTIVES
Compare the overall and cancer-specific survival of patients with prostate cancer treated with bicalutamide alone followed by bicalutamide with either goserelin or bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or bilateral orchiectomy
Compare the time to first and second clinical progression in patients treated with these regimens
Compare the quality of life including potency of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor differentiation grade G3 or Gleason more than 6 vs other values T category comorbidity ie chronic disease yes vs no potency yes vs no type of chosen hormonal ablation goserelin vs orchiectomy PSA level less than 10 ngmL vs 10-20 ngmL vs 20-100 ngmL and N status N0 vs NX Patients are randomized to one of two treatment arms
Arm I Patients receive oral bicalutamide once daily At first symptomatic disease progression patients also receive goserelin subcutaneously once every 28 or 84 days or undergo bilateral orchiectomy At second disease progression patients discontinue bicalutamide
Arm II Patients are observed until first symptomatic disease progression At first disease progression patients receive bicalutamide with either goserelin or bilateral orchiectomy as in arm I Patients discontinue bicalutamide as in arm I
Quality of life is assessed at baseline every 6 months for 6 years at each disease progression and then annually thereafter
Patients are followed annually
PROJECTED ACCRUAL Approximately 1266 patients 633 per treatment arm will be accrued for this study within 5 years
Compare the overall and cancer-specific survival of patients with prostate cancer treated with bicalutamide alone followed by bicalutamide with either goserelin or bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or bilateral orchiectomy
Compare the time to first and second clinical progression in patients treated with these regimens
Compare the quality of life including potency of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor differentiation grade G3 or Gleason more than 6 vs other values T category comorbidity ie chronic disease yes vs no potency yes vs no type of chosen hormonal ablation goserelin vs orchiectomy PSA level less than 10 ngmL vs 10-20 ngmL vs 20-100 ngmL and N status N0 vs NX Patients are randomized to one of two treatment arms
Arm I Patients receive oral bicalutamide once daily At first symptomatic disease progression patients also receive goserelin subcutaneously once every 28 or 84 days or undergo bilateral orchiectomy At second disease progression patients discontinue bicalutamide
Arm II Patients are observed until first symptomatic disease progression At first disease progression patients receive bicalutamide with either goserelin or bilateral orchiectomy as in arm I Patients discontinue bicalutamide as in arm I
Quality of life is assessed at baseline every 6 months for 6 years at each disease progression and then annually thereafter
Patients are followed annually
PROJECTED ACCRUAL Approximately 1266 patients 633 per treatment arm will be accrued for this study 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 |
|---|---|---|---|
| EORTC-GU-30991 | None | None | None |