Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
This study has been completed.
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
First received: June 20, 2005
Last updated: August 22, 2012
Last verified: August 2012
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.
Device: Prostate Immobilization Device
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2005 (Final data collection date for primary outcome measure)
- 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.
|Ages Eligible for Study:
||31 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
- Prostatic rectal fistula
- Stricture of anal canal
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114985
Dana-Farber Cancer Institute
Brigham and Women's Hospital
||Anthony V. D'Amico, MD, PhD
||Dana-Farber Cancer Institute
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.
||Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 20, 2005
||August 22, 2012
||United States: Institutional Review Board
Keywords provided by Dana-Farber Cancer Institute:
Total Androgen Suppression
3-D Conformal External Beam Radiation Therapy
Intra-rectal immobilization device
Quality of Life Assessment Questionnaire
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male