Clinical trial NCT03503097: Genetic Testing for Men With Metastatic Prostate Cancer
Official title: GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Keywords: Prostate cancer
metastatic
genetic testing
cancer risk
BRCA1
BRCA2
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-04-19
Enrollment: 799
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with metastatic prostate cancer

Brief summary: This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. The researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. Neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.

Detailed description: OUTLINE:

Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.

After study completion, participants are followed up at 6 months.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research trial information
* Documented evidence of metastatic prostate cancer;

  * Oncologist note within 4 months
  * All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months
  * All prostate-specific antigen (PSA) values within 12 months
  * All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy
* Willingness to provide basic demographic information, family cancer history, and treatment history
* Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up
* Willingness and ability to provide saliva sample

Exclusion Criteria:

* Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
* Incomplete inclusion criteria
* Study team members

Primary outcomes:
measure: Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)
timeFrame: From the start of study up to 3 years
measure: Patient reported outcome measures associated with genetic testing in men with mPC
timeFrame: From the time of enrollment up to 6-month follow-up
measure: Utility of family history to enrich screening of participants with mPC for germline homologous recombination deficiency (HRD) variants defined by collection of information about research participants' family history
timeFrame: From the start of study up to 3 years
measure: Identification of a cohort of men with prostate cancer and inherited HRD mutations
timeFrame: From the start of study up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather H. Cheng
role: PRINCIPAL_INVESTIGATOR
References: