Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003290
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques
Status:
COMPLETED
Status Verified Date:
2001-07
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 uses high-energy x-rays to damage tumor cells It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy
Compare the incidence of biochemical failure prostate-specific antigen PSA greater than 2 ngmL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50 development of metastases and survival in patients treated with these regimens
Compare the acute and late radiation-induced side effects of these regimens in this patient population
Compare aspects of quality of life health economics models of normal tissue and tumor control in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prostate-specific antigen T stage and Gleason score Patients are randomized to one of two treatment arms
All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy
Arm I Patients undergo standard conformal radiotherapy for 65 weeks
Arm II Patients undergo high-dose conformal radiotherapy for 75 weeks Quality of life is assessed at baseline every 6 months for 2 years and then annually thereafter
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study
Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy
Compare the incidence of biochemical failure prostate-specific antigen PSA greater than 2 ngmL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50 development of metastases and survival in patients treated with these regimens
Compare the acute and late radiation-induced side effects of these regimens in this patient population
Compare aspects of quality of life health economics models of normal tissue and tumor control in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prostate-specific antigen T stage and Gleason score Patients are randomized to one of two treatment arms
All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy
Arm I Patients undergo standard conformal radiotherapy for 65 weeks
Arm II Patients undergo high-dose conformal radiotherapy for 75 weeks Quality of life is assessed at baseline every 6 months for 2 years and then annually thereafter
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-98005 | None | None | None |
| MRC-RT01 | None | None | None |