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Trial registered on ANZCTR


Registration number
ACTRN12620000793910
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
7/08/2020
Date last updated
23/03/2023
Date data sharing statement initially provided
7/08/2020
Date results information initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Cancer Screening Study of 50-75 year old men using the combination test of Circulating Tumour Cells (CTC) and Prostate-Specific Markers
Scientific title
Determining the efficacy of a new Prostate Cancer Screening Test combining Circulating Tumour Cells (CTC) and Prostate-Specific Markers: a population-study of 50-75 year old men
Secondary ID [1] 301547 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of the ISET-CTC test study and related to the registration record ACTRN12614001143617. This study uses a combination of the ISET-CTC test and the PSA marker antibody test.

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 317910 0
Condition category
Condition code
Cancer 315949 315949 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Screening test: Combination of ISET-CTC test (ACTRN12614001143617) + prostate-specific (PSA) cell marker test using 10ml of patient's blood.

The ISET-CTC test = Isolation by SizE of Tumour Cells - Circulating Tumour Cell cytology-based blood test uses ISET technology (Rarecells, France) to isolate CTC from the blood. CTC count is related to cancer risk.
ICC with prostate specific (PSA) markers uses antibody methodology to identify whether the CTC cells have PSA surface markers or not.
Results of the screening test inform follow-up with diagnostic methods (prostate biopsy and/or PSMA-PET scan imaging).
Prostate-specific cell marker test using Immunocyto-chemistry (ICC).

The ISET-CTC and PSA marker screening tests will also be available to participants who do not enrol in this study.

A doctor’s referral is required for the Prostate Cancer Screening test.
Two clinic visits 2-4 weeks apart are required.
At Visit 1, 10 ml of blood will be taken at any pathology lab or doctor’s office.
A test kit can be requested for participants interstate and rural Victoria.
The patient's blood will be processed in the NIIM lab, Melbourne, VIC.
The CTC report will be sent to the referring doctor to discuss with the participants at visit 2, 2-4 weeks after the blood draw.

Follow-up of participants will be coordinated by the patients’ doctors as per usual clinical practice.
Routine and follow-up testing may include:
a) All participants: PSA-blood-tests
b) Participants with positive CTC count and positive PSA-marker results: Prostate specific tests, e.g PSMA-PET scans and/or prostate biopsy
c) Participants with positive CTC count and negative PSA-marker results: Non-prostate specific tests: MRI, PET scan and/or any other diagnostic tests, according to the patient’s doctor advice
d) Participants with a negative CTC count: As per doctor’s advice

Usual doctor’s consultation fee, additional blood tests, diagnostic testing such as scans, treatment costs may occur, and are not covered by the Study costs, and will be conducted at the participant's own cost at an external facility.
Intervention code [1] 317850 0
Early Detection / Screening
Comparator / control treatment
screening test result to be compared to gold standard diagnostic tests:
PSMA-PET scan or prostate biopsy results
Control group
Active

Outcomes
Primary outcome [1] 324154 0
Number of CTC / CTC count by cytology/microscopy
Timepoint [1] 324154 0
at time of blood draw
Primary outcome [2] 324155 0
PSA-marker positive or negative by Immuno-Cyto-chemistry
Timepoint [2] 324155 0
at time of blood draw
Secondary outcome [1] 383882 0
Comparison of screening test results with gold-standard diagnostic testing:
Diagnosis of Prostate Cancer:
Participants with positive CTC count and positive PSA marker results: will be advised by the referring doctor to undergo a follow-up diagnostic test by prostate-specific PSMA-PET scan imaging or biopsy.
In discussion with the doctor, the participants will choose their preferred diagnostic test.

Diagnosis of cancer: Participants with positive CTC count and negative PSA marker results: will be advised to undergo a follow-up non-prostate specific diagnostic test, e.g. MRI, PET scan, and/or any other diagnostic tests according to the patient's doctor's advice
Timepoint [1] 383882 0
4 weeks after CTC + PSA marker screening test

Eligibility
Key inclusion criteria
Men 50-75 years old
Primary group 1: men not diagnosed with cancer
Group 2: men diagnosed with prostate cancer (Test will provide probability of relapse or tumour progression)
Minimum age
50 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
men diagnosed with other cancers

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In this observational study, the CTC and PSA-marker results will be compared to the results of the follow-up tests including PSA blood marker, prostate-specific or non-prostate specific diagnostic tests, by sensitivity and specificity analysis, as outlined in our article.

The sample size for this study was based on the estimated incidence rate of prostate cancer:
In 2020, it is estimated that 16,741 new cases of prostate cancer will be diagnosed in Australia. In 2020, it is estimated that the age-standardised incidence rate is 110 cases per 100,000 males. Ref: https://prostate-cancer.canceraustralia.gov.au/statistics
Therefore, a sample size of 500 men is required to detect 55 cases of early prostate cancer.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2020
Actual
19/10/2020
Date of last participant enrolment
Anticipated
1/08/2022
Actual
20/12/2022
Date of last data collection
Anticipated
23/12/2022
Actual
23/12/2022
Sample size
Target
500
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 30580 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 305982 0
Charities/Societies/Foundations
Name [1] 305982 0
National Institute of Integrative Medicine
Country [1] 305982 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 306442 0
None
Name [1] 306442 0
Address [1] 306442 0
Country [1] 306442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306222 0
NIIM HREC
Ethics committee address [1] 306222 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 306222 0
Australia
Date submitted for ethics approval [1] 306222 0
17/06/2020
Approval date [1] 306222 0
12/10/2020
Ethics approval number [1] 306222 0

Summary
Brief summary
Prostate cancer is the most common in men, and the second leading cause of cancer deaths (25%) in Australia. One-in-Seven Australian men will be diagnosed with prostate cancer by aged 85, with more than 3,300 men dying each year.

Our recent research has provided evidence that our new screening test using the ISET®-Circulating Tumour Cells (CTC) Test and Prostate-specific Marker Test, can improve the early detection of Prostate Cancer. Our new prostate cancer screening test is markedly more accurate (True Positives: 99%, True Negatives: 97%) compared to the existing Prostate Specific Antigen (PSA) blood test (True Positives: 25%; True Negatives: 15%).

This study will determine the accuracy of a new prostate cancer screening blood test as compared to the current standard screening tests which generally involve blood tests, imaging scans and/or biopsy.

Who is it for?
You may be eligible for this study if you are a male aged between 50-75 years, either with no history of cancer, or if you have been previously diagnosed with prostate cancer.

Study details
All participants will be required to provide one blood sample at the time of enrolment into the study, which will be processed using the ISET technology to determine the number and types of Circulating Tumour Cells (CTC), as well as the levels of prostate-specific biomarkers. The CTC test report will be available for discussion with the referring doctor 2-4 weeks after the blood draw.
Participants who have a positive Prostate Cancer Screening Test result will be advised to undergo further assessment via imaging and/or biopsy of their prostate tissue. The PET imaging scan will involve injection of a radioactive tracing agent into your arm with a 30 minute delay before the scan is performed. It is anticipated that the scan will take approximately 2 hours to complete. If the referring doctor determines that a prostate biopsy is required, a tissue sample will be taken under local anaesthetic by an experienced doctor.

The aim of this research is to determine the accuracy of this simple blood test for the diagnosis of prostate cancer that can be used in the future as a cancer screening tool.
Trial website
www.niim.com.au/prostatecancertest
Trial related presentations / publications
Public notes
Study related publication:
Ried, K., Tamanna T, Matthews S, Eng P, Sali A. New Screening Test Improves Detection of Prostate Cancer Using Circulating Tumor Cells and Prostate-Specific Markers. Frontiers in Oncology April 2020, Volume 10, 582. https://pubmed.ncbi.nlm.nih.gov/32391268/

Contacts
Principal investigator
Name 103150 0
A/Prof Karin Ried
Address 103150 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 103150 0
Australia
Phone 103150 0
+61 03 9912 9545
Fax 103150 0
Email 103150 0
karinried@niim.com.au
Contact person for public queries
Name 103151 0
Karin Ried
Address 103151 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 103151 0
Australia
Phone 103151 0
+61 03 9912 9545
Fax 103151 0
Email 103151 0
karinried@niim.com.au
Contact person for scientific queries
Name 103152 0
Karin Ried
Address 103152 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 103152 0
Australia
Phone 103152 0
+61 03 9912 9545
Fax 103152 0
Email 103152 0
karinried@niim.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 summary data will be available. Due to privacy reasons, no individual data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.