Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

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.

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.

Total Androgen Suppression, Simulation, 3-D Conformal External Beam Radiation Therapy, Intra-rectal immobilization device, Quality of Life Assessment Questionnaire, Rectal Bleeding, Late effects

Inclusion Criteria: Biopsy proven prostate cancer Clinical Stage T1 - T4 Negative bone scan PSA and routine blood work >30 years of age ECOG Performance 0,1, or 2 No prior pelvic radiation No pacemaker Exclusion Criteria: Inflammatory bowel disease (Crohns, or Ulcerative Colitis) Prostatic rectal fistula Stricture of anal canal

Woel R, Beard C, Chen MH, Hurwitz M, Loffredo M, McMahon E, Ching J, Lopes L, D'Amico AV. Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):392-6. doi: 10.1016/j.ijrobp.2004.10.003.