The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000934246
Ethics application status
Approved
Date submitted
28/05/2018
Date registered
1/06/2018
Date last updated
10/06/2020
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Research study of patients after injection of TraceIT hydrogel for the treatment of their prostate cancer
Scientific title
Research study of patients after injection of an iodinated hydrogel (TraceIT®) before radiotherapy for localised prostate cancer
Secondary ID [1] 295022 0
None
Universal Trial Number (UTN)
U1111-1214-7596
Trial acronym
TraceIT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 308039 0
Condition category
Condition code
Cancer 307092 307092 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are eligible for this trial will consent to Radiation Therapy and the insertion of TraceIT hydrogel injection.
This appointment will involve both the Radiation Oncologist and the Urologist. A probe will be placed in your rectum and a numbing solution will be injected in the region between the anus and the genitals (known as the “perineum”). 10mL of the TraceIT® gel material will be introduced into the perineum using a long fine needle. The needle placement and injection will be guided by use of sound waves from the rectal probe, which is used to create a picture of the pelvic organs as the needle is advanced and the spacer material is deposited between the prostate and the rectum. Following injection, the needle and probe will be removed
An MRI and planning CT is performed 3-5 days post procedure.
Treatment planning and radiotherapy are delivered per departmental standards and include image guidance during radiation therapy, weekly review during treatment and regular follow-up post treatment.
The resorption of the gel will be assessed using MRI scans at the planning stage, 3 and 12 months post treatment.
Intervention code [1] 301352 0
Treatment: Devices
Comparator / control treatment
Data from patient treated with SpaceOAR in Frankston Radiation Oncology and Ringwood radiation Oncology practices from 31/12/2013 to 31/12/2015
Control group
Historical

Outcomes
Primary outcome [1] 306051 0
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.
Timepoint [1] 306051 0
MRIs will be taken at baseline, 3 months and 12 months post radiation therapy.
Secondary outcome [1] 347438 0
Treatment toxicity based on RTOG/EORTC Late Radiation Morbidity Scoring Schema

Timepoint [1] 347438 0
Up to and including 12 months post Radiation Therapy
Secondary outcome [2] 347439 0
Patient reported outcomes using the Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire
Timepoint [2] 347439 0
Questionnaires are provided at baseline, end of treatment, 3 months and 12 months

Eligibility
Key inclusion criteria
1. Patients with stage cT1-2N0M0 prostate cancer scheduled for primary curative prostate cancer radiotherapy
2. Able to provide written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Comparisons will be made between our SpaceOAR historical cohort and TraceIT population, evaluating the space created between the prostate and anterior rectal wall and the rectal doses using either paired T-test or Wilcoxon signed-rank test depending on if the distribution assumption is violated. We do not expect any difference in space created between the prostate and anterior rectal wall or dose received by the rectum between the two cohorts.
If this is a true effect then with 10 patients we have estimated a power between 0.95 and 1.00 to detect no difference. The table below shows the expected % rectal dose with SpaceOAR (calculated from 76 historical controls treated to 78Gy with same technique and submitted for publication) and the hypothesised dose with the use of TraceIT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11006 0
Ringwood Radiation Oncology Centre - Ringwood East
Recruitment hospital [2] 11007 0
Frankston Radiation Oncology Centre - Frankston
Recruitment postcode(s) [1] 22797 0
3135 - Ringwood East
Recruitment postcode(s) [2] 22798 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 299603 0
Commercial sector/Industry
Name [1] 299603 0
Genesis Cancer Care
Address [1] 299603 0
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country [1] 299603 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Genesis Cancer Care
Address
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 298923 0
None
Name [1] 298923 0
Address [1] 298923 0
Country [1] 298923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300503 0
'Bellberry Human Research Ethics G
Ethics committee address [1] 300503 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300503 0
Australia
Date submitted for ethics approval [1] 300503 0
30/04/2018
Approval date [1] 300503 0
13/06/2018
Ethics approval number [1] 300503 0

Summary
Brief summary
The purpose of this study is to assess the efficacy of the use of TraceIT for radiotherapy in prostate cancer when compared to SpaceOAR.

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer and is scheduled for primary curative prostate cancer radiotherapy.

Study details

All participants who are undergoing radiation therapy with the insertion of TraceIT as part of standard care. Using an MRI scan, we will follow up on the reabsorption of the TraceIT hydrogel over the 12 month period. This is in addition to the standard of care treatment.
Participants will also be asked to complete questionnaires to assess quality of life and overall experiences.
This study will assess the efficacy of the TraceIT product and further support and validate its use in our clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83874 0
Dr Michael Chao
Address 83874 0
Ringwood Private Hospital
36 Mount Dandenong Road
Ringwood East VIC 3135
Country 83874 0
Australia
Phone 83874 0
+61388703300
Fax 83874 0
Email 83874 0
mchao@radoncvic.com.au
Contact person for public queries
Name 83875 0
Dr Michael Chao
Address 83875 0
Ringwood Private Hospital
36 Mount Dandenong Road
Ringwood East VIC 3135
Country 83875 0
Australia
Phone 83875 0
+61388703300
Fax 83875 0
Email 83875 0
ringwoodreception@genesiscare.com.au
Contact person for scientific queries
Name 83876 0
Dr Michael Chao
Address 83876 0
Ringwood Private Hospital
36 Mount Dandenong Road
Ringwood East VIC 3135
Country 83876 0
Australia
Phone 83876 0
+61388703300
Fax 83876 0
Email 83876 0
ringwoodreception@genesiscare.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only grouped data will be used as per study protocol. publications avaliable on request by patient
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary