Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032006
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-03-08
Brief Title:
Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Status:
COMPLETED
Status Verified Date:
2016-07
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 Androgens can stimulate the growth of prostate cancer cells Drugs such as goserelin leuprolide flutamide or bicalutamide may stop the adrenal glands from producing androgens Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer
PURPOSE Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy
PURPOSE Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy
Detailed Description:
OBJECTIVES
Determine the nature intensity and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy
Determine the morbidity of patients treated with this regimen
Determine the overall survival disease-free survival and disease-specific survival of patients treated with this regimen
Determine the clinical patterns of tumor recurrence ie time to local tumor progression or distant failure and time to biochemical failure of patients treated with this regimen
Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive androgen suppression comprising goserelin subcutaneously as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection OR leuprolide intramuscularly as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days
Within 4 weeks after completion of androgen suppression patients are sequentially enrolled to 2 different cohorts of brachytherapy
Cohort 1 Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103
Cohort 2 After a minimum of 1-year follow-up for all patients in cohort 1 if tolerance is acceptable additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103
Quality of life is assessed at baseline within 2 weeks prior to brachytherapy every 3 months for 1 year and then every 6 months for 2 years
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 83-166 patients 83 per cohort will be accrued for this study within 15-3 years
Determine the nature intensity and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy
Determine the morbidity of patients treated with this regimen
Determine the overall survival disease-free survival and disease-specific survival of patients treated with this regimen
Determine the clinical patterns of tumor recurrence ie time to local tumor progression or distant failure and time to biochemical failure of patients treated with this regimen
Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive androgen suppression comprising goserelin subcutaneously as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection OR leuprolide intramuscularly as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days
Within 4 weeks after completion of androgen suppression patients are sequentially enrolled to 2 different cohorts of brachytherapy
Cohort 1 Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103
Cohort 2 After a minimum of 1-year follow-up for all patients in cohort 1 if tolerance is acceptable additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103
Quality of life is assessed at baseline within 2 weeks prior to brachytherapy every 3 months for 1 year and then every 6 months for 2 years
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 83-166 patients 83 per cohort will be accrued for this study within 15-3 years
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 |
|---|---|---|---|
| CDR0000069248 | REGISTRY | PDQ Physician Data Query | None |