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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 October 23, 2014
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site