A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rectal toxicity at six month intervals
Anthony V. D'Amico, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board