Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Device: Prostate Immobilization Device

Study type: Interventional

Funder types: Other

Identifiers

NCT00114985

01-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 31 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)