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Insulin-like growth factor (IGF)-mediated signaling is a newly recognizedclinical target in prostate cancer, and it is hypothesized that blockade of theIGF receptor (IGF1R) will impair downstream signaling and slow tumor growth. Inthis study the efficacy of nordihydroguaiaretic acid (NDGA), a small moleculeinhibitor of the IGF-1R, was prospectively evaluated in patients with non-metastatichormone-sensitive prostate cancer (HSPC). Eligible patients had non-metastaticHSPC with a rising prostate-specific antigen (PSA) and a normal testosterone level.NDGA 2000 mg was given orally daily in 28 day cycles and treatment continued untilPSA progression or toxicity. Accrual was stopped early after a pre-planned interimanalysis showed no significant PSA declines after 3 cycles of treatment amongthe first 12 patients enrolled. Median time on treatment was 9 cycles (range 2-19)for 11 patients now off study; 1 patient continues to receive therapy and hasbeen on study for 29 months. Seven patients experienced non-sustained declinesin PSA ranging from 1.9 to 15.8% of baseline. PSADT lengthened by a median of1.4 months for all evaluable patients when compared to pretreatment PSADT (range-6.1 to +19.8 months). Grade 3 events were rare and included nausea/vomiting,syncope due to dehydration, and elevated liver function tests in 1 patient, andcognitive disturbance in another patient. NDGA therapy lengthens median PSADTbut does not induce significant PSA declines. Further study may require a placebo-controlto determine if changes in PSADT are drug related.

oncology reports

A phase II study of insulin-like growth factor receptor inhibition with nordihydroguaiaretic acid in men with non-metastatic hormone-sensitive prostate cancer