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Correlation analyses of radiographic progression‐free survival with clinical and health‐related quality of life outcomes in metastatic castration‐resistant prostate cancer: Analysis of the phase 3 VISION trial

Background [177Lu]Lu–PSMA‐617 (177Lu‐PSMA‐617) plus protocol‐permitted standard of care (SOC) prolonged overall survival (OS) and radiographic progression‐free survival (rPFS) versus SOC in patients with prostate‐specific membrane antigen (PSMA)–positive metastatic castration‐resistant prostate canc...

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Published in:Cancer 2024-10, Vol.130 (20), p.3426-3435
Main Authors: Morris, Michael J., de Bono, Johann, Nagarajah, James, Sartor, Oliver, Wei, Xiao X., Nordquist, Luke T., Koshkin, Vadim S., Chi, Kim N., Krause, Bernd J., Herrmann, Ken, Rahbar, Kambiz, Vickers, Adrian, Mirante, Osvaldo, Ghouse, Ray, Fizazi, Karim, Tagawa, Scott T.
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Language:English
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Summary:Background [177Lu]Lu–PSMA‐617 (177Lu‐PSMA‐617) plus protocol‐permitted standard of care (SOC) prolonged overall survival (OS) and radiographic progression‐free survival (rPFS) versus SOC in patients with prostate‐specific membrane antigen (PSMA)–positive metastatic castration‐resistant prostate cancer (mCRPC) in the phase 3 VISION study, in addition to beneficial effects on symptomatic skeletal events (SSEs) and health‐related quality of life (HRQOL). Methods Post hoc analyses used the full analysis set from the VISION study (N = 831) overall and by randomized treatment arm (177Lu‐PSMA‐617 plus SOC, n = 551; SOC, n = 280). Correlations were determined between OS and rPFS and between rPFS or OS and time to SSE or to worsening HRQOL (Functional Assessment of Cancer Therapy–Prostate [FACT‐P] and 5‐level EQ‐5D [EQ‐5D‐5L]). Correlation analyses used an iterative multiple imputation copula‐based approach (correlation coefficients [rho] of 
ISSN:0008-543X
1097-0142
1097-0142
DOI:10.1002/cncr.35438