Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

May 2, 2023 updated by: Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Device: Prostate Immobilization Device

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 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rectal toxicity at six month intervals Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Time Frame: 2 years	2 years
urinary symptoms Time Frame: 2 years	2 years
sexual dysfunction at six month intervals Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria