In order to investigate the anticancer effect of DDW in humans a four-month long double-blind phase 2 placebo controlled clinical trial was conducted on prostate cancer (OGYI 5621/40/95). The primary outcome was the best response, and the agent's safety was also assessed. Forty-four patients were evaluated, 22 patients were involved in the treated-, and 22 patients in the placebo group, both groups received the same forms of conventional treatment. Summarizing the changes in prostate volume during the 4 months' period of the trial in the treated group a net decrease of 160.3 cm3 was achieved, on the contrary, the result was 54 cm3 in the control group. During the extended follow-up of the 44 patients, in the first year (from the date of entering the trial), 2 patients (9.1%) died in the treated group and 9 patients (40.9%) in the placebo group (significantly lower mortality in the treated group; Fisher's Exact Test, p=0.034).
In addition, beside the 44 evaluated patients in the phase 2 clinical trial, the course of the disease was also retrospectively evaluated in 91 patients consuming DDW parallel with the conventional forms of treatment. 20 out of 91 retrospectively followed patients developed distant metastasis within one year after the diagnosis. The median survival time (MST) was 5.4 year, while the historical control is 1.2-1.6 years.
The results suggest that DDW might reduce the mortality of prostate cancer, since it was able to delay progression as well as to prolong MST in patients with histologically confirmed prostate cancer.
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