Changing paradigms in the treatment of metastatic castration-resistant prostate cancer (mCRPC) continues as a theme for our second issue. New advancements in include not only mechanisms for the identification of recurrent and progressive disease but also for interpreting resistance patterns and the options of therapeutic decision making. In particular, it is well established that bone metastases and their resultant skeletal complications may have a devastating impact on patient quality of life, individual morbidity as well as significant health economic implications for our prostate cancer patients. This edition’s lead article is entitled, “Bone Metastases and Mortality in Prostate Cancer: Can We Be Doing More?”. Here we present the higher mortality, economic burden, and quality of life impairment experienced by men with bone metastatic disease.
The basic science and preclinical development for abiraterone began in the 1990s, and culminated as the 1st oral novel hormonal agents approved for a survival benefit both after and before the use of taxane based therapy. As the Principle Investigator for the Phase III COU-AA-302 clinical trial, Charles Ryan, reflects on the trial’s strategic development: including methodology of the studies two co-primary endpoints as well as the important secondary endpoints. Dr. Ryan’s expert perspective provides clarity and insights regarding the trials design considerations, the data collection, and the key endpoints achieved: overall survival and progression free survival efficacies, which led to its unique registration approval in 2012. While these co-primary endpoints were important for regulatory approval, Dr. Ryan shares why the collective trial data when considered for our mCRPC patients has solidified abiraterone as landmark development for the treatment of advanced prostate cancer. In this edition, Dr. Ryan shares his perspective on the regulatory development chapter of the abiraterone journey leading to its approval. In a forthcoming issue Dr. Ryan will share how to optimally assesses the patient for the selection of abirarterone in clinical practice.
As radiographic modalities evolve with greater accuracy, with evidenced based improved sensitivity and specificity, clinicians may detect both micro-and macro metastatic disease earlier and with improved precision. As an example, Axumin™ [18F] fluciclovine is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment, and received FDA approval in May 2016. PET imaging with [11C] choline has been shown to improve detection in men with prostate cancer, however its use has been limited to only medical centers with on-site 11C production capability. The Axumin scan has been shown to provide an accurate imaging approach for patients with very low PSA relapse after interventional modalities, e.g., surgical extirpation or radiation therapy. Karen Linder of Blue Earth Diagnostics Ltd provides us additional insights about the utility of Axumin in the Clinical Update article. She provides an overview on the evidence based data for Axumin and its position amongst comparator imaging modalities.
In each issue of Everyday Urology, we will provide a Spotlight section, with rotating topics of interest. This month’s spotlight is provided by Bishoy Faltas, a member of our editorial board and an instructor of medicine at Weill Cornell Medicine and an Assistant Attending in the Genitourinary Oncology Program in the Division of Hematology and Medical Oncology. Dr. Faltas provides commentaries of noteworthy articles he has selected from recently published journals of high impact. We share these journal abstracts along with his commentary. These author commentaries are also shared on UroToday’s section, Beyond the Abstracts.
Thank you for your continued interest and for reading this issue of Everyday Urology- Oncology Insights.
Neal Shore, MD, FACS