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These include prostate-specific antigen (PSA), human kallikrein 2, trypsin, and cathepsin D, which were identified to degrade IGFBPs, thus releasing free mitogenic IGF-I ( When compared to the benign prostate epithelium, primary prostate cancer had higher levels of IGF-1R expression, which is further escalated in metastasis ( In vitro , studies indicated that IGF-I stimulated the proliferation of various prostate cancer cell lines (22Rv1 and DU145) by the activation of the AKT/ERK/MAPK pathway ( In vivo , PC-3 tumors proliferate at a considerably slower rate in IGF-I-deficient hosts than in IGF-I-expressing hosts ( in vivo studies reported that the blocking of IGF-1R in combination with castration inhibited prostate cancer growth ( IGFBP-3 is the most prevalent form of the IGFBPs, which has been linked with prostatic growth

All establishments concerned and affected Marketing Authorization Holders are hereby strongly advised to coordinate with the FDA to pursue remedial actions, including the necessary measures to address the regulatory and safety concerns regarding the subject product, that may warrant the issuance of an updated health advisory or the lifting of this Advisory, among others

& Simon, M