Skip to main content
OpenTrials
Completed

NCT Number: NCT00114985

Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

31 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate Immobilization Device

Device

Device placed during radiation treatment

Primary outcomes

  1. Rectal toxicity at six month intervals

    Time frame: 2 years

Secondary outcomes

  1. Quality of Life

    Time frame: 2 years

  2. urinary symptoms

    Time frame: 2 years

  3. sexual dysfunction at six month intervals

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2005
Study completion
2008
First posted
Jun 21, 2005
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.