MedicalResearch.com Interview with:
Andrew J. Armstrong, MD ScM FACP
Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology
Associate Director for Clinical Research in Genitourinary Oncology
Duke Cancer Institute
Divisions of Medical Oncology and Urology
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Men with prostate cancer commonly develop bone metastases and undergo nuclear medicine bone scans. However, these scans are non-quantitative, and disease burden has been challenging to assess over time and to relate to clinical outcomes.
We developed a software program and measurement called the automated bone scan index that essentially reads a standard of care nuclear bone scan, provides a quantitative metric, and demonstrate in a phase 3 trial that this aBSI is highly associated with clinical outcomes including survival, time to symptomatic progression, and prostate cancer specific survival.
We accomplished this within a prospective phase 3 international trial of men with metastatic hormone resistant prostate cancer who were followed over a long period of time. All bone scans were read and measured using the aBSI at baseline, and we found that the aBSI was highly prognostic. This work validates prior smaller phase 2 BSI studies, and demonstrates both the feasibility and clinical utility for incorporating the aBSI into clinical practice to provide this important prognostic information to patients and providers.
MedicalResearch.com: What should readers take away from your report?
Response: Our hope is that the aBSI will help in several ways:
1) to provide prognostic information to patients and their physicians/providers
2) to identify those men most likely to benefit from bone targeting anti-cancer therapies, and
3) to develop aBSI as an endpoint in clinical studies to demonstrate the effectiveness of therapies aimed at improving or stabilizing bone metastases over time in patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Now that aBSI has passed through this phase 3 prognostic analysis successfully, we need to further identify what changes in aBSI are clinically important over time in response to standard and novel therapies, such that survival is improved. This may provide an intermediate endpoint for drug development of prostate cancer and bone targeting therapies. Measuring the aBSI as part of the standard of care practice in addition to the standard qualitative nuclear medicine report will enable such research to take place on a large effectiveness scale. The software, which is essentially free, enables an aBSI to be calculated in seconds to minutes, and we hope will accelerate discovery and development of agents that can attack or prevent bone metastases by allowing a better way to measure and quantify bone metastases in patients.
MedicalResearch.com: Is there anything else you would like to add?
Response: Research was funded by Exini (Sweden) who makes the aBSI software, but who provides this software at no charge. Reviewers were blinded to clinical outcomes.
Armstrong AJ, Anand A, Edenbrandt L, et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate CancerA Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. Published online May 17, 2018. doi:10.1001/jamaoncol.2018.1093
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