Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

NCT ID: NCT00114985

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2008-10-31

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Prostate Immobilization Device

Device placed during radiation treatment

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Anthony V. D'Amico, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony V. D'Amico, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

References

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.

Reference Type: BACKGROUND

PMID: 15890580 (View on PubMed)

Other Identifiers

01-050

Identifier Type: -

Identifier Source: org_study_id