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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

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]

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

Condition category

Condition code

Cancer

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]

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]

Number of CTC / CTC count by cytology/microscopy

Timepoint [1]

at time of blood draw

Primary outcome [2]

PSA-marker positive or negative by Immuno-Cyto-chemistry

Timepoint [2]

at time of blood draw

Secondary outcome [1]

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]

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]

3122 - Hawthorn

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Institute of Integrative Medicine

Address [1]

21 Burwood Rd
Hawthorn VIC 3122

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NIIM HREC

Ethics committee address [1]

National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/06/2020

Approval date [1]

12/10/2020

Ethics approval number [1]

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

A/Prof Karin Ried

Address

National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

+61 03 9912 9545

Fax

[email protected]

Contact person for public queries

Name

Karin Ried

Address

National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

+61 03 9912 9545

Fax

[email protected]

Contact person for scientific queries

Name

Karin Ried

Address

National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

+61 03 9912 9545

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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