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Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials.

Publication ,  Journal Article
Mota, JM; Armstrong, AJ; Larson, SM; Fox, JJ; Morris, MJ
Published in: Prostate Cancer Prostatic Dis
December 2019

BACKGROUND: Up to 90% of men with metastatic castration-resistant prostate cancer (mCRPC) will have a distribution of disease that includes bone metastases demonstrated on a Technetium-99m (99mTc-MDP) bone scan. The Prostate Cancer Working Group 2 and 3 Consensus Criteria standardized the criteria for assessing progression based on the development of new lesions. These criteria have been recognized by regulatory authorities for drug approval. The bone scan index (BSI) is a method to quantitatively measure the burden of bony disease, and can assess both disease progression and regression. The automated BSI (aBSI) is a method of computer analysis to assess BSI, and is being qualified as a clinical trials endpoint. METHODS: Manual searching was used to identify the literature on BSI and aBSI. We summarize the most relevant aspects of the retrospective and prospective studies evaluating aBSI measurements, and provide a critical discussion on the potential advantages and caveats of aBSI. RESULTS: The development of neural artificial networks (EXINI boneBSI) to automatically determine the BSI reduces the turnaround time for assessing BSI with high reproducibility and accuracy. Several studies showed that the concordance between aBSI and BSI, as well as the interobserver concordance of aBSI, was >0.95. In a phase 3 assessment of aBSI, a doubling value increased the risk of death in 20%, pre-treatment aBSI values independently correlated with overall survival (OS) and time to symptomatic progression. Retrospective studies suggest that a decrease in aBSI after treatment may correlate with higher survival when compared with increasing aBSI. CONCLUSIONS: aBSI provides a quantitative measurement that is feasible, reproducible, and in analyses to date correlates with OS and symptomatic progression. These findings support the aBSI to risk-stratify men with mCRPC for clinical trial enrollment. Future studies quantifying aBSI change over time as an intermediate endpoint for evaluating new systemic therapies are needed.

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Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

December 2019

Volume

22

Issue

4

Start / End Page

522 / 530

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Risk Assessment
  • Reproducibility of Results
  • Radiopharmaceuticals
  • Radionuclide Imaging
  • Prostatic Neoplasms, Castration-Resistant
  • Prognosis
  • Patient Selection
  • Organotechnetium Compounds
  • Male
 

Citation

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ICMJE
MLA
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Mota, J. M., Armstrong, A. J., Larson, S. M., Fox, J. J., & Morris, M. J. (2019). Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials. Prostate Cancer Prostatic Dis, 22(4), 522–530. https://doi.org/10.1038/s41391-019-0151-4
Mota, Jose Mauricio, Andrew J. Armstrong, Steven M. Larson, Josef J. Fox, and Michael J. Morris. “Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials.Prostate Cancer Prostatic Dis 22, no. 4 (December 2019): 522–30. https://doi.org/10.1038/s41391-019-0151-4.
Mota JM, Armstrong AJ, Larson SM, Fox JJ, Morris MJ. Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):522–30.
Mota, Jose Mauricio, et al. “Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials.Prostate Cancer Prostatic Dis, vol. 22, no. 4, Dec. 2019, pp. 522–30. Pubmed, doi:10.1038/s41391-019-0151-4.
Mota JM, Armstrong AJ, Larson SM, Fox JJ, Morris MJ. Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):522–530.

Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

December 2019

Volume

22

Issue

4

Start / End Page

522 / 530

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Risk Assessment
  • Reproducibility of Results
  • Radiopharmaceuticals
  • Radionuclide Imaging
  • Prostatic Neoplasms, Castration-Resistant
  • Prognosis
  • Patient Selection
  • Organotechnetium Compounds
  • Male