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Trial registered on ANZCTR


Registration number
ACTRN12616000495426
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
15/04/2016
Date last updated
13/03/2019
Date data sharing statement initially provided
13/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing Predictive and Prognostic Molecular Biomarkers in Prostate Cancer
Scientific title
Assessing Predictive and Prognostic Molecular Biomarkers in Prostate Cancer
Secondary ID [1] 288909 0
None
Universal Trial Number (UTN)
U1111-1181-4887
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 298244 0
Condition category
Condition code
Cancer 298385 298385 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
0-10
Target follow-up type
Years
Description of intervention(s) / exposure
Enrolled patients will undergo collection of clinical data and tumour and blood specimens, as well as any archival tissue that is available. For those patients who undergo a planned resection or biopsy of a “current” metastatic tumour specimen, a sample will be collected from residual tissue that contains tumour – this is referred to as fresh tissue.
Patients that consent to the “liquid biopsy” (blood collection) will undergo collection of blood at the beginning and end of each systemic therapy. Archival tumour specimens and “current” fresh biopsy tumour specimens will be stored at designated site-specific laboratories. Blood products will be stored frozen in a -70C at designated site-specific laboratories.
Enrolled patients will have clinical data collected for the life of the project or until patient death. This may range between 1 to 10 years dependent on when the patient enrolls.
Intervention code [1] 294372 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297859 0
To identify and validate molecular prognostic and predictive biomarkers in prostate cancer that can be used to identify patients who have poorer survival or who will not respond to particular treatments.
Biomarkers will be identified through modern molecular techniques, which include:
- Multiplexed microarrays, used to determine relative expression changes
- Quantitative PCR, used to measure copy numbers of genes and determine relative expression changes
- Immunohistochemistry to identify expression of proteins
- Next generation sequencing, used to determine mutations present in prostate cancer
As molecular techniques are constantly evolving, other novel methodologies may be used.
Once potential biomarkers have been discovered statistical analysis will be used to determine significance.
Timepoint [1] 297859 0
Follow up will occur at each of these timepoints:
Primary diagnosis: tissue will be analysed, and clinical data accessed to determine initial diagnosis.
New diagnosis of metastatic disease: tissue will be analysed, and clinical data will be analysed to see previous treatments, general health, site of new disease.
Treatments: blood samples will be taken at the beginning and end of any systemic treatment given.
Generally, clinical data will be collected on a patients health for up to 10 years or until patient death.
Secondary outcome [1] 322468 0
To examine the level of concordance of molecular biomarkers identified in both primary tumour and metastatic tumour specimens.
Timepoint [1] 322468 0
Primary tumour sample accessed at enrolment, and metastatic tumour specimen obtained at time of diagnosis of metastatic disease. Clinical data analysed until 10 years post study commencement or until patient death.

Eligibility
Key inclusion criteria
1. Age >18 years
2. Histological or cytological diagnosis of prostate cancer
3. Archival tumour specimen is available for molecular analysis
4. Able to be accessible for follow-up and data collection
5. Written, voluntary and informed consent for biopsy
6. Able to undergo core needle biopsy of metastases (patients must have a lesion which is deemed medically safe to biopsy)
7. Written, voluntary and informed consent for blood collection
8. Able to undergo collection of blood specimen at the beginning of each new systemic therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. No archival tumour is specimen available for molecular analysis
2. Unable to be accessible for follow-up and data collection

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Sample size calculations for detection of a biomarker present in either 10%, 20% or 33% of patients with castration-resistant prostate cancer have been calculated. In this scenario, the systemic treatment results in a PSA response rate of 30% or greater. Additionally, the biomarker is able to identify patients where the same systemic treatment results in a PSA response rate of 5% or less. Using an Alpha of 0.05 and Power of 0.80, our planned study population of 500 patients is able to detect a clinically significant predictive biomarker (as defined by being present in at least 10% of patients and resulting in a PSA response rate of 10% or less).
Descriptive statistics will be used to analyse data arising directly from this protocol study. The Kaplan-Meier method and the Mantel-Cox log-rank test will be used for survival analyses. Proportions will be compared using the Chi square method or Fisher’s exact test. For all analyses, two-sided p values of < 0.05 will be considered significant. Multivariate survival analyses will use the Cox Proportional Hazards method.

Recruitment
Recruitment status
Recruiting
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] 5567 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5568 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 5569 0
Epworth Freemasons - Melbourne
Recruitment hospital [4] 5570 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 13025 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 13026 0
3002 - East Melbourne
Recruitment postcode(s) [3] 13027 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 293297 0
Other Collaborative groups
Name [1] 293297 0
Walter and Eliza Hall Institute
Address [1] 293297 0
1G Royal Parade
PARKVILLE, Vic, 3052
Country [1] 293297 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute
Address
1G Royal Parade
PARKVILLE, Vic, 3052
Country
Australia
Secondary sponsor category [1] 292101 0
None
Name [1] 292101 0
Address [1] 292101 0
Country [1] 292101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294772 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 294772 0
PO The Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
Ethics committee country [1] 294772 0
Australia
Date submitted for ethics approval [1] 294772 0
24/11/2014
Approval date [1] 294772 0
03/02/2015
Ethics approval number [1] 294772 0
HREC/14/MH/342

Summary
Brief summary
The primary purpose of this study is to identify biological markers in tumour and blood samples which may predict clinical outcomes and response to treatment in prostate cancer patients.

Who is it for?: You may be eligible to participate in this study if you are aged 18 or over, with a diagnosis of prostate cancer of which a tumour specimen has already been taken and is available for further testing.

Study details: All participants in this study will have a small sample of their tissue (primary and metastatic) that was taken at diagnosis used for research. Researchers will look at the DNA inside the tissue and see if they can find any 'markers' that may make patients respond better to certain types of treatments. A blood sample will also be taken at the start and at the end end of any treatment you may have. Researchers will also use medical records to correlate any biological markers with disease outcomes. It is hoped that the findings of this study will lead to the identification and validation of biological markers which may allow more personalised treatment for future prostate cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64882 0
Dr Ben Tran
Address 64882 0
Medical Oncology
Royal Melbourne Hospital
Grattan Street
PARKVILLE, Victoria, 3050
Country 64882 0
Australia
Phone 64882 0
+61 (0)3 9342 7818
Fax 64882 0
Email 64882 0
ben.tran@mh.org.au
Contact person for public queries
Name 64883 0
Dr Ben Tran
Address 64883 0
Medical Oncology
Royal Melbourne Hospital
Grattan Street
PARKVILLE, Victoria, 3050
Country 64883 0
Australia
Phone 64883 0
+61 (0)3 9342 7818
Fax 64883 0
Email 64883 0
ben.tran@mh.org.au
Contact person for scientific queries
Name 64884 0
Dr Ben Tran
Address 64884 0
Medical Oncology
Royal Melbourne Hospital
Grattan Street
PARKVILLE, Victoria, 3050
Country 64884 0
Australia
Phone 64884 0
+61 (0)3 9342 7818
Fax 64884 0
Email 64884 0
ben.tran@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results