IAS trials currently under investigation

Table 2. lists the trials comprising IAS treatment of prostate cancer patients registered in the United States National Institute of Health (NIH) clinical studies site. With exception of a few further trials comparing IAS to CAS in metastatic cancer patients, several drugs are investigated for their potential to prolong the off-treatment phase of IAS. Exisulind (Aptosyn or su-lindac sulfone) may be useful as a treatment for men with advanced prostate cancer, achieving disease stabilization. This drug increases the rate of programmed cell death in cancer cells without damaging normal tissue by interfering with cyclic GMP phosphodies-terase in abnormally growing precancerous and cancerous cells [45]. Zactima (vandetanib) is an oral inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), epidermal growth factor receptor (EGFR) and Ret tyrosine kinases involved in tumor growth, progression and angiogenesis [46]. Although, as single agent, no significant antitumor activity has been observed for Zactima in small cell lung cancer, advanced ovarian, colorectal, breast, prostate cancer and multiple myeloma. Further drugs target the androgen-stimulated growth by exploiting distinct mechanism or new formulations. Dutasteride is a non-selective inhibitor of steroid 5a-reductase, an enzyme responsible for conversion of testosterone to a more potent androgen dihydrotestosterone (DHT) approved for clinical use in treat ment of benign prostate hyperplasia (BPH) and currently tested in clinical trials for prevention and treatment of prostate cancer [47]. Degarelix is a GnRH antagonist, that was found to be at least as effective as leuprolide in the ability to suppress serum testosterone to < or =0.5 ng/mL for up to 1 year in prostate cancer patients in different doses and in depot form [48]. Finally, Eligard constitutes a new leuprorelin acetate formulation that appears to achieve a testosterone suppression of 20 ng/dL in 98% of patients, while maintaining a side effect profile comparable to other products in its class [49]. It remains to be investigated, whether this use of drugs targeting androgen-independent mechanisms or improving AS can prolong the duration of the off-treatment periods of IAS and, possibly, contribute to extended survival compared to CAS.

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