PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness

Study Overview
=================
Brief Summary
-----------------
PROMISE aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, PSA greater than 100 ng/dL and/or radiographic evidence of disease and receiving systemic therapy for prostate cancer. Patients at all stages of disease will be welcome to participate in the PROMISE Registry. Participants will be recruited & screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results. Participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures. PROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data. Participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants. Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years. The PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for. For more information, visit the study website at: prostatecancerpromise.org

Official Title
-----------------
PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Genetic Testing
* Behavioral: Genetic Counseling
* Behavioral: Patient Reported Outcome Measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following: tissue biopsy, and/or PSA greater than 100 ng/dL (1ng/ml), and/or clear radiographic evidence of disease Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands) Exclusion Criteria: Unable or unwilling to provide all of the necessary information for eligibility Incomplete inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with at least one germline pathogenic/likely pathogenic variant<br> | Behavioral: Genetic Testing<br>* Germline genetic testing via Color Health's Hereditary Cancer Panel.<br>Behavioral: Genetic Counseling<br>* A Genetic Counselor will review results with participants and discuss clinical implications and recommendations.<br>Behavioral: Patient Reported Outcome Measures<br>* Participants will complete the EORTC QLQ-C30 questionnaire every 6 months.<br>|
| Other: Participants with at least one variant of uncertain significance<br> | Behavioral: Genetic Testing<br>* Germline genetic testing via Color Health's Hereditary Cancer Panel.<br>Behavioral: Genetic Counseling<br>* A Genetic Counselor will review results with participants and discuss clinical implications and recommendations.<br>Behavioral: Patient Reported Outcome Measures<br>* Participants will complete the EORTC QLQ-C30 questionnaire every 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of at least one germline pathogenic or likely pathogenic variant | Frequency of having at least one germline pathogenic or likely pathogenic variant in a cancer risk gene based on the number of subjects screened. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pathogenic or likely pathogenic germline variants of interest | Frequency of pathogenic or likely pathogenic germline variants of interest in subjects with prostate cancer. We will estimate the frequency of having each of the germline pathogenic or likely pathogenic variant in the cancer risk genes based on the number of subjects screened in each subpopulation. | 5 years | 
| Identify and recruit control group of patients with a variant of uncertain significance (VUS) | Identify and recruit a control group of patients with a VUS in their clinical or research results in the following genes: ATM, ATR, BARD1, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2. | 5 years | 
| Association between disease characteristics and genetic variants | Collect data on disease characteristics and examine the association between disease characteristics and pathogenic and likely pathogenic germline variants and VUS of interest. | 15 years | 
| Analysis of patient reported outcomes (PRO) measures | Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30. | 15 years | 
| Analysis of longitudinal outcome data | Collect longitudinal outcome data on subjects with pathogenic and likely pathogenic germline variants and VUS of interest, for specific treatments, treatment sequences or therapy combinations used for treating prostate cancer. | 15 years | 
| Comparison of overall survival | Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS. | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Genetics, Registry, Germline Mutation, Genetic Testing, Germline Testing