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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

799

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.1 years study duration

Study Start

First participant enrolled

August 21, 2017

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

April 11, 2018

Last Update Submit

September 26, 2025

Conditions

Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8

Keywords

Prostate cancermetastaticgenetic testingcancer riskBRCA1BRCA2

Outcome Measures

Primary Outcomes (4)

Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)
Frequency to be determined by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.
From the start of study up to 3 years
Patient reported outcome measures associated with genetic testing in men with mPC
Outcome measures to be defined by patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up.
From the time of enrollment up to 6-month follow-up
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
To be determined by collection of information about research participants' family history that includes cancer history (diagnosis, age of onset, treatment, etc.) but will not include identifiers of family members. This information will be used to examine which self-reported family history criteria may be associated with identification of cancer predisposition syndrome.
From the start of study up to 3 years
Identification of a cohort of men with prostate cancer and inherited HRD mutations
Identification to be determined through the Washington state cancer registry, through mail-out to all urologists and medical oncologists in the state of Washington, and through the Seattle Cancer Care Alliance Network sites. In addition, web-based advertising and recruiting will occur more broadly through the U.S., including at partnering sites.
From the start of study up to 3 years

Study Arms (1)

Ancillary-Correlative (questionnaires, Color kit, counseling)

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 DNA repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.

Procedure: Biospecimen CollectionOther: Genetic CounselingOther: Genetic TestingOther: Laboratory Biomarker AnalysisBehavioral: Questionnaire