Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003312
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
1999-11-01
Brief Title:
Brachytherapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2014-01
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 Giving radiation therapy through seeds implanted into the prostate may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of brachytherapy in treating patients with stage I or stage II prostate cancer
PURPOSE Phase II trial to study the effectiveness of brachytherapy in treating patients with stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES I Evaluate the effectiveness of transrectal ultrasound guided permanent radioactive implantation of the prostate in patients with confined adenocarcinoma of the prostate II Assess the overall survival disease specific survival clinical relapse local or distant PSA levels and genitourinary and gastrointestinal morbidity in these implant patients III Assess the quality of life of these patients
OUTLINE This is a multicenter study Patients receive transrectal ultrasound guided radioactive I-125 seeds implanted into the prostate At least one week prior to implant patients undergo transurethral ultrasound study to determine the volume of prostate Following implantation seeds that have extruded into the bladder or lodged in the urethral wall are retrieved and extra seeds may be implanted into identified cold spots for uniform seed distribution Prostate rebiopsy is required before starting hormonal therapy for local progression or biochemical failure without clear focus of progression Quality of life is assessed every 3 months for 1 year then every 6 months for 1 year and then annually for 3 years Patients are followed every 3 months for 1 year then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive transrectal ultrasound guided radioactive I-125 seeds implanted into the prostate At least one week prior to implant patients undergo transurethral ultrasound study to determine the volume of prostate Following implantation seeds that have extruded into the bladder or lodged in the urethral wall are retrieved and extra seeds may be implanted into identified cold spots for uniform seed distribution Prostate rebiopsy is required before starting hormonal therapy for local progression or biochemical failure without clear focus of progression Quality of life is assessed every 3 months for 1 year then every 6 months for 1 year and then annually for 3 years Patients are followed every 3 months for 1 year then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000066259 | None | None | None |