Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002889
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
1999-11-01
Brief Title:
Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER A PROSPECTIVE PHASE II STUDY
Status:
COMPLETED
Status Verified Date:
2023-08
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 Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy
PURPOSE Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy
PURPOSE Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy
Detailed Description:
OBJECTIVES I Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate
OUTLINE Patients undergo a baseline endorectal coil MRI followed by total androgen suppression TAS with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months Patients then receive a second endorectal coil MRI followed by 2 months of external-beam radiotherapy plus TAS Patients may receive an additional 2 months of TAS at the discretion of the treating physician Patients are followed every 6 months for 3 years then yearly thereafter
PROJECTED ACCRUAL Approximately 180 patients approximately 60 per year will be accrued for this study over a 34 months
OUTLINE Patients undergo a baseline endorectal coil MRI followed by total androgen suppression TAS with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months Patients then receive a second endorectal coil MRI followed by 2 months of external-beam radiotherapy plus TAS Patients may receive an additional 2 months of TAS at the discretion of the treating physician Patients are followed every 6 months for 3 years then yearly thereafter
PROJECTED ACCRUAL Approximately 180 patients approximately 60 per year will be accrued for this study over a 34 months
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-9682 | None | None | None |
| CDR0000065212 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |