Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091390
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2004-09-07
Brief Title:
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
Status:
COMPLETED
Status Verified Date:
2020-07
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 and other sources to damage tumor cells Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer
PURPOSE This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate
Secondary
Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen
Determine freedom from biochemical failure in patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine disease-specific survival of patients treated with this regimen
Determine clinical relapse local andor distant in patients treated with this regimen
Develop a quality assurance process for high-dose rate prostate brachytherapy
OUTLINE This is a multicenter study Patients are stratified according to prostate-specific antigen 10 ngmL vs 11-20 ngmL T stage T1c-T2c vs T3a-T3b combined Gleason score 2-6 vs 7 vs 8-10 prior hormonal therapy no vs yes and timing of high-dose rate brachytherapy before external beam radiotherapy vs after external beam radiotherapy
Patients are followed at 3 7 9 and 12 months every 6 months for 5 years and then annually thereafter
Primary
Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate
Secondary
Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen
Determine freedom from biochemical failure in patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine disease-specific survival of patients treated with this regimen
Determine clinical relapse local andor distant in patients treated with this regimen
Develop a quality assurance process for high-dose rate prostate brachytherapy
OUTLINE This is a multicenter study Patients are stratified according to prostate-specific antigen 10 ngmL vs 11-20 ngmL T stage T1c-T2c vs T3a-T3b combined Gleason score 2-6 vs 7 vs 8-10 prior hormonal therapy no vs yes and timing of high-dose rate brachytherapy before external beam radiotherapy vs after external beam radiotherapy
Patients are followed at 3 7 9 and 12 months every 6 months for 5 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000382120 | None | None | None |