Prostate cancer: Use case examples incorporating genetic testing, molecular diagnostics, and patient reported outcomes and patient generated wearable data from early diagnosis to advanced disease.

Three Takeaways:

1. To understand the use of molecular diagnosis for genetic counseling and therapeutic decision making for prostate cancer.
2. To assess how the combination of patient reported outcomes and wearables can assist symptom attenuation, and improved resource utilization
3. To describe how we are educating the future generation of health care providers (undergraduate, graduate and post-graduate) in digital health and informatics so they are empowered to improve patient’s lives.

Prostate cancer (PCA) is the second most commonly diagnosed cancer among men globally, with more than 1.1 million new cases each year.  In the United States, 233,000 men are expected to be diagnosed in 2014, and an American man’s lifetime risk of prostate cancer is 1 in 6.  With the introduction of genomic diagnostics and novel therapeutics, the past 5 years have seen an explosion in the amount of new data and opportunities for clinical benefit to prostate cancer patients.  This presentation will discuss how; 1) We incorporate molecular profiling to provide guidance re: therapeutics options, 2) genetic evaluation continuum for inherited PCA and 3) the use of patient reported outcomes (PROs) combined with wearables to identify patients who are experiencing symptoms related to therapy and mitigate potential serious toxicity.

The presentation is arranged in a logical progression from screening and prevention to diagnosis, treatment and surveillance.  We will discuss advances in molecular pathology using cancer genomics that have now entered the clinical realm and our research that helped in part for one of these genomic signatures to receive FDA and CMS approval.  We will cover covering novel molecular and genotype profiling in prostate cancer, including morphometric and systems pathology and current uses of radiographic imaging for diagnosis and staging.  Precision medicine is catapulting the need for genetic testing to inform cancer treatment, particularly in the advanced-stage setting.

We will describe the Philadelphia Prostate Cancer Consensus 2017 that was the first attempt to garner expert opinion consensus on key areas in the genetic evaluation continuum for inherited PCA. Increasing scientific insights into the genetic predisposition to inherited PCA, growing multigene testing capabilities, and limited guidelines necessitated expert consensus to address genetic counseling and genetic testing, PCA screening, and management. This conference brought together key stakeholders in PCA treatment, genetic counseling, research, and advocacy to consider the evidence and develop a working framework for genetic counseling, genetic testing, and management of inherited PCA in the multigene testing era.

We will describe genetic counseling for prostate cancer and the need focused development.  We will describe how the genetic counseling model should include shared decision making between provider and patient regarding genetic testing. The discussion should clarify patient values and preferences related to screening, risk assessment, and treatment choice.  Counseling elements of genetic education; discussion of benefits, risks, and limitations of genetic testing for patients and families; financial implications; and genetic discrimination laws are also important to discuss. Optimal delivery of pretest genetic counseling to patients in the multigene testing era, particularly for genetic testing for advanced/metastatic cancers for targetable mutations, is an area under development.

We will discuss the decision process for treatment recommendation and the quality of life components, critical, for any therapeutic option.  We will describe how we incorporate models of care delivery, patient navigation for the multidisciplinary care of prostate cancer patients, genomics and risk assessment and comparative effectives research in treatment decision-making.

In the last portion of the talk we will discuss, patient-reported outcomes (PROs) that can also be used to manage toxicity in of cancer treatment, helping patients to stay on treatment longer.  In addition, PROs are of interest to the FDA to demonstrate safety.  Accurate, inexpensive, commercially available wearable sensors open up new possibilities for monitoring patients’ vital signs, physical activity, and sleep.  Taken together, these parameters can be used to gauge toxicity and can serve as a proxy for overall quality of life.  It is expected that remote activity monitoring will increasingly be used in the context of clinical trials and standard care to improve toxicity management and be used for survivorship and wellness post cancer treatment.

We will end with a description of how we are educating the future generation of health care providers (undergraduate, graduate and post-graduate) in digital health and informatics so they have the skill sets to improve patient’s lives.