Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00114985

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Device: Prostate Immobilization Device	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Rectal toxicity at six month intervals [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
urinary symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
sexual dysfunction at six month intervals [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	April 2001
Study Completion Date:	October 2008
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Device placed during radiation treatment

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.

Eligibility

Ages Eligible for Study:	31 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114985

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Anthony V. D'Amico, MD, PhD

Dana-Farber Cancer Institute

More Information

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.

Responsible Party:	Anthony D'Amico, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00114985 History of Changes
Other Study ID Numbers:	01-050
Study First Received:	June 20, 2005
Last Updated:	June 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Total Androgen Suppression
Simulation
3-D Conformal External Beam Radiation Therapy
Intra-rectal immobilization device

Quality of Life Assessment Questionnaire
Rectal Bleeding
Late effects

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012