Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00114985
First received: June 20, 2005
Last updated: August 22, 2012
Last verified: August 2012
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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 2 |
| 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:
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:
Detailed Description:
-
Device: Prostate Immobilization Device
Device placed during radiation treatment
- 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 More Information
Publications:
| Responsible Party: | Anthony V. D'Amico, MD, PhD, Principal Investigator, 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: | August 22, 2012 |
| 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 May 21, 2013