Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063882
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2003-07-08
Brief Title:
Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-12
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 Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES
Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy EBRT
Compare biochemical ie prostate-specific antigen failure biochemical failure by the Phoenix definition disease-specific survival local progression and distant metastases in patients treated with these regimens
Compare morbidity and quality of life of patients treated with these regimens
Determine the feasibility of collecting Medicare data in a large Radiation Therapy Oncology Group RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT
Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage T1c vs T2a or T2b Gleason score 6 vs 7 prostate-specific antigen 10 ngmL vs 10-20 ngmL and prior neoadjuvant hormonal therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo external beam radiotherapy 5 days a week for 5 weeks Within 2-4 weeks of radiotherapy patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds
Arm II Patients undergo interstitial brachytherapy only as in arm I Quality of life is assessed at baseline at 4 12 and 24 months and then annually for 3 years
After completion of study treatment patients are followed at 3-5 weeks at 4 6 9 and 12 months every 6 months for 4 years and then annually thereafter
Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy EBRT
Compare biochemical ie prostate-specific antigen failure biochemical failure by the Phoenix definition disease-specific survival local progression and distant metastases in patients treated with these regimens
Compare morbidity and quality of life of patients treated with these regimens
Determine the feasibility of collecting Medicare data in a large Radiation Therapy Oncology Group RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT
Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage T1c vs T2a or T2b Gleason score 6 vs 7 prostate-specific antigen 10 ngmL vs 10-20 ngmL and prior neoadjuvant hormonal therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo external beam radiotherapy 5 days a week for 5 weeks Within 2-4 weeks of radiotherapy patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds
Arm II Patients undergo interstitial brachytherapy only as in arm I Quality of life is assessed at baseline at 4 12 and 24 months and then annually for 3 years
After completion of study treatment patients are followed at 3-5 weeks at 4 6 9 and 12 months every 6 months for 4 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 |
|---|---|---|---|
| NCI-2009-01091 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000288823 | None | None | None |