Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104741
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2005-03-03
Brief Title:
Triptorelin Flutamide and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis
Status:
COMPLETED
Status Verified Date:
2021-02
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 cause the growth of prostate cancer cells Drugs such as triptorelin and flutamide may stop the adrenal glands from making androgens Radiation therapy uses high-energy x-rays to kill tumor cells Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer
PURPOSE This randomized phase III trial is studying triptorelin flutamide and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer
PURPOSE This randomized phase III trial is studying triptorelin flutamide and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer
Compare the survival rate in terms of 5-year clinical or biological remission in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Compare acute and late toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conformal external beam radiotherapy
Arm II Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily Androgen blockade therapy continues for a total of 4 months Two months after initiation of androgen blockade therapy patients undergo conformal external beam radiotherapy
Quality of life is assessed
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study
Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer
Compare the survival rate in terms of 5-year clinical or biological remission in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Compare acute and late toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conformal external beam radiotherapy
Arm II Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily Androgen blockade therapy continues for a total of 4 months Two months after initiation of androgen blockade therapy patients undergo conformal external beam radiotherapy
Quality of life is assessed
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20503 | None | None | None |
| FRE-FNCLCC-GETUG-140207 | None | None | None |