Spots Global Cancer Trial Database for Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

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Trial Identification

Brief Title: Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

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 ID: NCT00114985

Conditions

Prostate Cancer

Interventions

Prostate Immobilization Device

Study Description

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.