Genetic Evaluation of Men (GEM)

Study Overview
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Brief Summary
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This is a prospective research registry and prospective genetic testing cohort study. The goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.

Detailed Description
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Objectives: Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility. Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process. Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk. Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk. Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Official Title
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Genetic Evaluation of Men (GEM)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: GEM Registry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with a personal history of prostate cancer Unaffected males who are at higher risk for prostate cancer Exclusion Criteria: Age < 18 years Mental or cognitive impairment that interferes with ability to provide informed consent Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gem Registry<br>Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer | Other: GEM Registry<br>* Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family cancer history collection | Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility. | Three years | 
| Behavioral measure collection | Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process | Three years | 
| Biospecimen bank | Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk | Three years | 
| Genetic and genomic sequencing | Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk | Three years | 
| Participant follow-up | Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk. | Three years |