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Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose

NCT02212548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-14

No results posted yet for this study

Summary

This is a Phase I prospective study of 30 patients to determine whether PEG hydrogel (SpaceOAR) reduces the dose of radiation delivered to the rectum during Image Guided Intensity Modulated Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space between the prostate and the rectum.

Conditions

  • Cancer of the Prostate

Interventions

DEVICE

PEG Hydrogel (SpaceOAR)

A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.

Sponsors & Collaborators

  • Royal North Shore Hospital

    lead OTHER

Principal Investigators

  • Thomas Eade, MD · Royal North Shore Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-12-31
Completion
2016-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212548 on ClinicalTrials.gov