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Trial registered on ANZCTR


Registration number
ACTRN12619000502134
Ethics application status
Approved
Date submitted
25/03/2019
Date registered
28/03/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
28/03/2019
Date results information initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a mainstream model of genetic testing for men with prostate cancer
Scientific title
Evaluation of a mainstream model of genetic testing for men with prostate cancer
Secondary ID [1] 297797 0
Nil known
Universal Trial Number (UTN)
U1111-1230-5963
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 312154 0
Condition category
Condition code
Cancer 310699 310699 0 0
Prostate
Human Genetics and Inherited Disorders 310732 310732 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be offered germline genetic testing by a member of their treating oncology team:
- Patients will receive pre-test genetic counselling by member of their treating team, including provision of a general information sheet about the testing
- Participants will then have testing performed by collection of a saliva sample, with testing performed for 16 prostate cancer genes (ATM, BRCA1, BRCA2, CHEK2, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PMS2, TP53, FANCA, PALB2, RAD51D, BRIP1)

Once patients have received their results, they will immediately be provided witha questionnaire evaluating acceptability of the testing process
- a reminder questionnaire will be sent in the mail 4 weeks after the initial questionnaire, if they fail to return a completed questionnaire
Intervention code [1] 314036 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319551 0
Acceptability of a mainstream model of genetic testing, via a study-specific questionnaire
Timepoint [1] 319551 0
after receiving results of genetic testing
Secondary outcome [1] 368647 0
Proportion of men who accepted germline genetic testing
Timepoint [1] 368647 0
at completion of study
Secondary outcome [2] 368648 0
Rate of germline mutations in men with prostate cancer as detected via panel of tests performed on saliva sample
Timepoint [2] 368648 0
At completion of test
Secondary outcome [3] 368649 0
Exploratory qualitative responses to study specific questionnaire (including specific questions on information preferences, people involved in patient's decision to undergo testing and patient's understanding of results)
Timepoint [3] 368649 0
After receiving results of genetic testing
Secondary outcome [4] 368650 0
Modified Multidimensional impact of Cancer Risk assessment score
Timepoint [4] 368650 0
After receiving results of genetic testing

Eligibility
Key inclusion criteria
Retrospective file review of men with prostate cancer who have been offered mainstreaming of germline testing for an inherited cause of prostate cancer.

Participants who will be provided with the questionnaire include:
- Men greater than or equal to 18 years old
- Diagnosed with Prostate cancer
- Have had mainstreaming of germline testing performed for inherited causes of prostate cancer
- Read in English
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse the survey responses.

A sample size of 44 men will provide 90% power to distinguish a proportion of men who are happy with mainstreaming of 80% vs. 60% or less, with a one-sided alpha of 0.05. Allowing for 25% drop-out, we aim to recruit 60 men. A rate of men happy with testing of over 80% will be considered worthwhile.

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)
NSW
Recruitment hospital [1] 13479 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 13480 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 26094 0
2139 - Concord
Recruitment postcode(s) [2] 26095 0
2050 - Camperdown
Recruitment postcode(s) [3] 29940 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 302321 0
Other Collaborative groups
Name [1] 302321 0
Sydney Catalyst, the Translational Cancer Research Centre of central Sydney and regional NSW
Address [1] 302321 0
LIfehouse Building
Level 6
119 - 143 Missenden Road
Camperdown NSW 2050
Country [1] 302321 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119 - 146 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 302202 0
None
Name [1] 302202 0
Address [1] 302202 0
Country [1] 302202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302994 0
Sydney Local Health District Ethics Review Committee (RPAH zone)
Ethics committee address [1] 302994 0
Ethics Review Committee (RPAH zone)
Research Ethics and Governance Office
Royal Prince Alfred Hospitak
Camperdown NSW 2050
Ethics committee country [1] 302994 0
Australia
Date submitted for ethics approval [1] 302994 0
27/09/2018
Approval date [1] 302994 0
05/12/2018
Ethics approval number [1] 302994 0
X18-0399 and HREC/18/RPAH/574

Summary
Brief summary
The National Comprehensive Cancer Network guidelines now suggest testing all men with metastatic prostate cancer for germline mutations predisposing to cancer, the purpose of this study is to determine whether this kind of testing is acceptable to patients with prostate cancer.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer.

Study details:
The study involves having a discussion with a member of your treating oncology team about genetic testing for an inherited gene that may have predisposed to developing prostate cancer.

If you agree to the testing, we will collect a saliva sample and send it for testing. The results will be available in about 4 weeks. If your result shows a change in one of the genes that we are testing for, that may have contributed to your development of prostate cancer, then we will refer you for a consultation with the Familial Cancer Service.

After your oncologist provides you with the test result, we will provide you with a questionnaire, asking you about your opinion on the testing process.

It is hoped that this study will help determine if the testing process is acceptable to patients with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92106 0
Prof Lisa Horvath
Address 92106 0
Chris O'Brien Lifehouse
119 - 146 Missenden Road
Camperdown NSW 2050
Country 92106 0
Australia
Phone 92106 0
+61 285140000
Fax 92106 0
Email 92106 0
lisa.horvath@lh.org.au
Contact person for public queries
Name 92107 0
Dr Tahlia Scheinberg
Address 92107 0
Chris O'Brien Lifehouse
119 - 146 Missenden Road
Camperdown NSW 2050
Country 92107 0
Australia
Phone 92107 0
+61 285140000
Fax 92107 0
Email 92107 0
tahlia.scheinberg@lh.org.au
Contact person for scientific queries
Name 92108 0
Dr Tahlia Scheinberg
Address 92108 0
Chris O'Brien Lifehouse
119 - 146 Missenden Road
Camperdown NSW 2050
Country 92108 0
Australia
Phone 92108 0
+61 285140000
Fax 92108 0
Email 92108 0
tahlia.scheinberg@lh.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
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary