Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114985
• Other study ID #: 01-050
• Status: Completed
• Phase: Phase 2
• Start date: April 2001
• Est. completion date: October 2008

Study information

• Verified date: May 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2008
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 31 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Prostate Immobilization Device
Device placed during radiation treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rectal toxicity at six month intervals		2 years
Secondary	Quality of Life		2 years
Secondary	urinary symptoms		2 years
Secondary	sexual dysfunction at six month intervals		2 years