Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003026
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Hormone Therapy in Treating Patients With Advanced 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:
Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-06
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 Androgens can stimulate the growth of prostate cancer cells Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens
PURPOSE Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression
PURPOSE Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression
Detailed Description:
OBJECTIVES
Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome overall survival clinical disease free survival local regional control quality of life treatment side effects sexual function and health economy cost effectiveness ratio
OUTLINE This is a randomized multicenter study
Patients receive external radiation for 5 weeks followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation Flutamide Eulexin or bicalutamide Casodex may be used as the antiandrogens Antiandrogen treatment starts 1 week before the first injection of triptorelin
Patients are then randomized to one of two treatment arms
Arm I Patients receive no further treatment
Arm II Patients receive antiandrogen for 25 years plus and LHRH analogue triptorelin administered every 3 months Patients then continue the LHRH analogue alone for an additional 25 years in the absence of disease progression
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 966 patients will be accrued over 5 years
Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome overall survival clinical disease free survival local regional control quality of life treatment side effects sexual function and health economy cost effectiveness ratio
OUTLINE This is a randomized multicenter study
Patients receive external radiation for 5 weeks followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation Flutamide Eulexin or bicalutamide Casodex may be used as the antiandrogens Antiandrogen treatment starts 1 week before the first injection of triptorelin
Patients are then randomized to one of two treatment arms
Arm I Patients receive no further treatment
Arm II Patients receive antiandrogen for 25 years plus and LHRH analogue triptorelin administered every 3 months Patients then continue the LHRH analogue alone for an additional 25 years in the absence of disease progression
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 966 patients will be accrued over 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-22961 | None | None | None |
| EORTC-22961 | None | None | None |