Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114985
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2005-06-20
Brief Title:
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
Status:
COMPLETED
Status Verified Date:
2023-05
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:
During 3D-conformal external beam radiation therapy treatments for prostate cancer the prostate gland moves The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation
Detailed Description:
MRI using an endorectal coil done prior to treatment for staging
Baseline Quality of Life QOL assessment will be completed prior to treatment
Total androgen suppression is initiated and will continue for at least 6 months
Prostate Immobilization Device PID placed during the planning session
PID will be placed daily for the first 15 3D external beam radiation treatments
QOL assessment and follow-up will take place every 6 months for 3 years
Baseline Quality of Life QOL assessment will be completed prior to treatment
Total androgen suppression is initiated and will continue for at least 6 months
Prostate Immobilization Device PID placed during the planning session
PID will be placed daily for the first 15 3D external beam radiation treatments
QOL assessment and follow-up will take place every 6 months for 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