Status:

COMPLETED

Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

Brigham and Women's Hospital

Conditions:

Prostate Cancer

Eligibility:

MALE

31-80 years

Phase:

PHASE2

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 immobilizati...

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...

Eligibility Criteria

Inclusion

  • 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

  • Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
  • Prostatic rectal fistula
  • Stricture of anal canal

Key Trial Info

Start Date :

April 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00114985

Start Date

April 1 2001

End Date

October 1 2008

Last Update

May 3 2023

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