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Evaluation of a mainstream model of genetic testing for men with prostate cancer

Evaluation of a mainstream model of genetic testing for men with prostate cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000502134
Enrollment
63
Registered
2019-03-28
Start date
2019-04-17
Completion date
2019-11-06
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

Chris O'Brien Lifehouse
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026