EXECUTIVE SUMMARY

Introduction: This unique, global forum will review the state of art and future directions in diagnostic solutions, which have been recognized as the central challenge in prostate cancer care. The key leaders of medicine, science, advocacy, industry, government, legislation, public policy and professional organizations care will be brought together to achieve the following goals:
  • To educate about the emerging diagnostic advances, which are critical for creating a personalized imaging information and genetic blueprint for every man in order to ensure a precision approach to screening, early detection and treatment;
  • To bridge the currently existing gaps among the experts working on multi-disciplinary diagnostic tools (e.g., biomarkers, imaging, genomics, genetics, etc); and 
  • To create a consensus-based vision for the future and effective strategy for its realization.

 

Primary Focus: To stimulate a multi-disciplinary discussion on clinical strategies for –
  • Improving early detection (and exclusion) of clinically significant prostate cancer, which is defined as having a potential to progress, cause metastases and death; and
  • Decreasing over-diagnosis and over-treatment of benign and low-risk (sub-clinical, or indolent) diseases, which are not likely to cause symptoms in a man’s lifetime.

 

Rationale: Prostate cancer is the most common major cancer in the United States, striking as many as 1 in 7 men. While curable when detected early, prostate cancer remains the second most lethal malignancy in men. And yet, there has been a continuous controversy surrounding current screening tools, largely due to under-diagnosis of life-threatening prostate cancer and over-diagnosis of indolent, low-risk diseases.  
The Statement of Science published by the National Institutes of Health identified the need to advance diagnostic tools for accurate prediction of prostate cancer progression as the critical health research priority.

 

Mission: To facilitate transfer of promising research and innovations from laboratories to clinics by:
  • Fostering a multi-disciplinary dialogue between the leading experts in radiology, urology, radiation oncology, medical oncology, pathology, molecular biology, genetics, genomics and other specialties;
  • Reviewing the cutting-edge advances and challenges in prostate cancer diagnostics and their integration with research, education, awareness, advocacy and health care policy; and
  • Creating a strategic plan for the expedited development, clinical evaluation and implementation of emerging diagnostic tools.

 

Target Audience and Overall Goal: This conference will educate the key health care stakeholders, including physicians, scientists, advocates, consumers, educators, policy makers, and representatives of the corporate, regulatory and reimbursement communities and the general public about emerging diagnostic advances in prostate cancer diagnostics, review their potential impact on patient care and outline a strategy for their clinical evaluation and implementation.

 

Specific Aims: A population-based review of the emerging and future diagnostic solutions for the current clinical needs and challenges, related cost-benefit considerations and potential roadmaps for precision, personalized patient care.
  1. Non-invasive screening in general (asymptomatic) patient population, when testing (e.g., biomarkers and imaging) is conducted to identify men at a higher risk of clinically significant prostate cancer.
  2. Diagnostic assessment of men with abnormal screening, when PSA is abnormal and/or there is a clinical suspicion of clinically significant prostate cancer. This discussion will include:> How to improve risk stratification, including selection of patients for biopsies. This discussion will address such a major public health issue as reduction of unnecessary biopsies performed in over 1 million men each year in the United States alone (when biopsies find mostly benign tissue or non-aggressive disease); and > How to improve biopsy tissue sampling compared to the current ultrasound-guided procedures, which are “blind” to cancer, fail to analyze over 99% of the prostate and lead to:
    i. The under-estimation of cancer aggressiveness in at least 37% of patients; and
    ii. Missing over 50% of aggressive, life-threatening malignancies altogether.
  3. Diagnostic assessment of men with clinically proven prostate cancer, including location, aggressiveness and staging, in order to improve selection of patients for treatment. This discussion will include:
    • How to improve biopsy tissue analysis, including genomic testing and molecular pathology;
    • How to improve multi-factorial prediction of aggressive prostate cancer and selection of patients for early treatment to decrease metastases and mortality. While prostate cancer is curable when detected early, an American man dies every 18 minutes;
    • How to decrease unnecessary treatment performed in over 90,000 men each year in the United States alone. This discussion will include novel approaches to increasing confidence in indolent (dormant), or sub-clinical disease for improved selection of patients for active surveillance and other observation strategies.
  4. Discussion of the impact of novel diagnostic tools on the creation of optimal, cost-effective strategies for precision, personalized patient care: Giving every man the best chance.

 

Milestones and Deliverables:
  • Preparing and publishing a consensus paper;
  • Establishing a multi-disciplinary “Brain Trust” that will:
    1. Integrate efforts of the key multi-disciplinary leaders in patient care, including diagnostic tools;
    2. Outline a consensus-based scientific strategy and the related priority research projects;
    3. Stimulate novel ideas and expand groundbreaking research and innovation;
  • Increasing participation of the attending faculty members and industrial investigators in prostate cancer research;
  • Educating the attending health care providers, advocates, consumers, patients and members of the general public about the emerging, cutting-edge trends in clinical care and research, including clinical trials;
  • Expanding education of patients in order to increase their demand for cutting-edge advances in diagnostic tools and their participation in clinical trials in order to improve outcomes;
  • Reviewing emerging scientific evidence and its current and potential impact on regulatory, reimbursement and health care policies.