Research study of patients after injection of TraceIT hydrogel for the treatment of their prostate cancer

Not Applicable

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618000934246
• Lead Sponsor: Genesis Cancer Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-01
• Study Completion: 2020-01-31
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

1. Patients with stage cT1-2N0M0 prostate cancer scheduled for primary curative prostate cancer radiotherapy
2. Able to provide written consent

Exclusion Criteria

1. Women
2. Patient ineligible or unwilling to consent to radiation therapy to the prostate
3. Patients ineligible or unwilling to consent to the insertion of a Spacer, specifically TraceIT®
a. Patients allergic to iodine or shellfish

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to evaluate the efficacy of the TraceIT product. This will be assessed by evaluating the space created between the prostate and anterior rectal wall through the use of an MRI at 3 different time points. In each of these scans, we will assess the changes in visibility, in combination with, the resorption of the hydrogel over time.[MRIs will be taken at baseline, 3 months and 12 months post radiation therapy.]

Secondary Outcome Measures

Name	Time	Method
Treatment toxicity based on RTOG/EORTC Late Radiation Morbidity Scoring Schema<br><br>[Up to and including 12 months post Radiation Therapy];Patient reported outcomes using the Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire [Questionnaires are provided at baseline, end of treatment, 3 months and 12 months]