None listed
Conditions
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.
Interventions
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 o
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.
Sponsors
AProf Dr Karin Ried
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Healthy volunteers
Yes
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)
Exclusion criteria
men diagnosed with other cancers
Outcome results
None listed