Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00114985

Enrollment

100

Registered

2005-06-21

Start date

2001-04-30

Completion date

2008-10-31

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Total Androgen Suppression, Simulation, 3-D Conformal External Beam Radiation Therapy, Intra-rectal immobilization device, Quality of Life Assessment Questionnaire, Rectal Bleeding, Late effects

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.

Interventions

DEVICEProstate Immobilization Device

Device placed during radiation treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

31 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rectal toxicity at six month intervals	2 years

Secondary

Measure	Time frame
Quality of Life	2 years
urinary symptoms	2 years
sexual dysfunction at six month intervals	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026