Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450411
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2007-03-20
Brief Title:
Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Status:
COMPLETED
Status Verified Date:
2022-05
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 Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells
PURPOSE This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy
PURPOSE This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy
Detailed Description:
OBJECTIVES
Primary
Determine the late treatment-related gastrointestinal GI and genitourinary GU adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy
Secondary
Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the disease-specific survival of patients treated with this regimen
Determine clinical patterns of tumor recurrence time to local tumor progression or distant failure in patients treated with this regimen
Determine the time to biochemical failure in patients treated with this regimen
Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen
OUTLINE This is a prospective multicenter study
Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
Primary
Determine the late treatment-related gastrointestinal GI and genitourinary GU adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy
Secondary
Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the disease-specific survival of patients treated with this regimen
Determine clinical patterns of tumor recurrence time to local tumor progression or distant failure in patients treated with this regimen
Determine the time to biochemical failure in patients treated with this regimen
Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen
OUTLINE This is a prospective multicenter study
Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 96 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 |
|---|---|---|---|
| CDR0000533887 | None | None | None |