Banner MD Anderson Cancer Center

Biomarkers and Clinical Decisions – Integrating with Clinical Parameters, Imaging & Prognostic Instruments

Matthew R. Cooperberg, MD, MPH, Professor of Urology and Epidemiology & Biostatistics and Helen Diller Family Chair in Urology at the University of California, San Francisco (UCSF), outlines the current role of biomarkers in clinical decision-making for prostate cancer. In the first part of the presentation, he discusses markers for pre-diagnosis evaluation, noting that candidate markers have to improve on an existing multivariable gold standard, have to identify potentially lethal prostate cancer, and should be held to the same standard as other biomarkers. Dr. Cooperberg goes over the tests that are currently available, and considers where markers belong in the testing sequence. He observes that liquid markers have better negative predictive value for high-grade cancer than MRI does, and also emphasizes the continued importance of systematic biopsy. He then explains the emerging UCSF diagnostic sequencing approach, in which patients with an elevated marker receive a biopsy regardless of MRI results. In the next part of the presentation, Dr. Cooperberg looks at the relatively stagnant state of post-diagnosis markers. According to him, risk groups are outdated and need to be replaced. He then summarizes the 2nd San Francisco Consensus Statement on this matter, which says that a putative biomarker must be shown to improve on an existing, validated, multivariable model reflecting all available clinical information, and explains that while some biomarkers meet this criteria, they are not yet standard of care. Dr. Cooperberg concludes that the liberal use of secondary tests to aid decision-making before and after biopsy helps drive balance of risks and harms in favor of early baseline PSA screening with low initial threshold, that MRI can help target biopsy and stage cancer but does not replace need for initial systematic biopsy, and that no test is binary.

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Future Directions in Molecular and Multi-Modality Imaging and Theranostics of Prostate Cancer

Phillip J. Koo, MD, Division Chief of Diagnostic Imaging and Northwest Region Oncology Physician Executive at the Banner MD Anderson Cancer Center in Phoenix, Arizona, discusses the clinical, research, and educational targets that will advance nuclear medicine’s future role in prostate cancer treatment. He proposes that physicians should consider nuclear medicine the fourth pillar of a cancer specialty, not only for its role in diagnostics but also due to the increased use of radiopharmaceuticals. Dr. Koo reviews results from the TheraP and VISION trials that illustrate the efficacy of PSMA PET/CT, the current diagnostic standard in clinical care. Dr. Koo then describes how nuclear medicine clinicians and radiologists can partner with medical oncologists in clinical settings to create patient-friendly, multidisciplinary care models. This model further integrates nuclear medicine clinicians and radiologists into diagnostic and therapeutic discussions, with the aim of determining the appropriate type of therapy faster. Relatedly, he sees an opportunity for nuclear medicine physicians to lead clinical trials as principal investigators. Dr. Koo concludes with a discussion about the role of education, contending that exposing medical students and residents to nuclear medicine is key to developing a future workforce.

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Imaging Strategies for GU Cancers: PSMA PET

In conversation with E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, Phillip J. Koo, MD, Division Chief of Diagnostic Imaging and Northwest Region Oncology Physician Executive at the Banner MD Anderson Cancer Center in Phoenix, Arizona, discusses the recent FDA approval of Gallium (Ga) 68 PSMA-11 PET/CT and its implications for prostate cancer care. Dr. Koo discusses the indications for use approved by the FDA, noting the emphasis on PSMA PET/CT’s role in treating oligometastatic disease. He observes that it is still unclear what impact the availability of PSMA PET will have on patient care and outcomes, but suggests that studies like the ORIOLE trial indicate that better imaging will lead to better outcomes. Dr. Koo then goes over the availability and potential of different PSMA imaging agents, noting that while Ga 68 PSMA-11 is the only approved agent and has the benefit of being a generic product, it is prohibitively difficult to manufacture and its supply may always be limited. Not-yet-approved alternatives like the Ga 68 PSMA kit, F-18 PyL, and F-18 rhPSMA could all potentially be easier to distribute but may be very expensive. Dr. Koo also mentions that coverage might be a concern for PSMA generally, and he argues that physicians must fight to ensure that insurance pays for PSMA imaging. The talk concludes with a Q&A session during which Drs. Crawford and Koo discuss whether PSMA will replace bone scans and how PSMA compares to MRI.

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Timing and Optimization of Radium 223 in CRPC

Phillip J. Koo, MD, briefly reviews several clinical trials examining the use of radium 223, focusing on its use in combination with second generation AR inhibitors. He also reviews the data from the ERA 223 trial that was recently reported at ESMO 2018 and discuss lessons learned, including the optimal use of radium 223 in patients with endocrine resistant prostate cancer.

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