Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
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|ClinicalTrials.gov Identifier: NCT00114985|
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Prostate Immobilization Device||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||October 2008|
Device: Prostate Immobilization Device
- Rectal toxicity at six month intervals [ Time Frame: 2 years ]
- Quality of Life [ Time Frame: 2 years ]
- urinary symptoms [ Time Frame: 2 years ]
- sexual dysfunction at six month intervals [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114985
|Principal Investigator:||Anthony V. D'Amico, MD, PhD||Dana-Farber Cancer Institute|