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Improving power in PSA response analyses of metastatic castration-resistant prostate cancer trials. | LitMetric

Improving power in PSA response analyses of metastatic castration-resistant prostate cancer trials.

BMC Cancer

Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.

Published: January 2022

AI Article Synopsis

  • - The study investigates whether an augmented analysis approach can enhance the efficiency of PSA response evaluations in metastatic castration-resistant prostate cancer trials, which typically just compare baseline PSA data to a threshold without fully utilizing continuous data.
  • - A literature review identified 64 articles with continuous PSA data, allowing for a comparison between traditional analysis and this augmented method, which showed a median efficiency gain equivalent to a 103.2% increase in sample size effectiveness.
  • - The findings suggest that using the augmented analysis requires no extra data collection and can be easily implemented with available software, potentially reducing the number of participants needed in prostate cancer trials, thus speeding up the process and lowering costs.

Article Abstract

Background: To determine how much an augmented analysis approach could improve the efficiency of prostate-specific antigen (PSA) response analyses in clinical practice. PSA response rates are commonly used outcome measures in metastatic castration-resistant prostate cancer (mCRPC) trial reports. PSA response is evaluated by comparing continuous PSA data (e.g., change from baseline) to a threshold (e.g., 50% reduction). Consequently, information in the continuous data is discarded. Recent papers have proposed an augmented approach that retains the conventional response rate, but employs the continuous data to improve precision of estimation.

Methods: A literature review identified published prostate cancer trials that included a waterfall plot of continuous PSA data. This continuous data was extracted to enable the conventional and augmented approaches to be compared.

Results: Sixty-four articles, reporting results for 78 mCRPC treatment arms, were re-analysed. The median efficiency gain from using the augmented analysis, in terms of the implied increase to the sample size of the original study, was 103.2% (IQR [89.8,190.9%]).

Conclusions: Augmented PSA response analysis requires no additional data to be collected and can be performed easily using available software. It improves precision of estimation to a degree that is equivalent to a substantial sample size increase. The implication of this work is that prostate cancer trials using PSA response as a primary endpoint could be delivered with fewer participants and, therefore, more rapidly with reduced cost.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8793251PMC
http://dx.doi.org/10.1186/s12885-022-09227-7DOI Listing

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