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Lecture 12 (Part1/2) of 1st International Deuterium Symposium

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Published on May 20, 2010

G. Somlyai: Deuterium depletion as an effective treatment option for prostate cancer - statistical evaluation of a double blind, randomized phase II clinical trial and a retrospective study on prostate cancer

About the lecture:
1) G. Somlyai, 2) I. Guller, 1) K. Krempels, 1) I. Somlyai, 2) A. Kovács
1) HYD LLC. for Cancer Research and Drug Development, Budapest, Hungary,
2) Saint Johns Hospital, Budapest, Hungary
In order to investigate whether DDW might exert an anticancer effect in humans and improve the results of conventional treatments, a four-month long double blind, phase II, placebo controlled clinical trial was conducted on prostate cancer. In addition, beside the 44 evaluated patients in the phase II clinical trial, the course of the disease was also retrospectively evaluated in 91 patients consuming DDW parallel with the conventional forms of treatments.
Summarizing the changes in prostate volume during the 4 months period of the phase II clinical 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. Furthermore, in those 7 patients, who achieved PR (p=0.046), the prostate volume became smaller by 125.2 cm3 in total, and the patients reached 32%, 64%, 18%, 70%, 47%, 20%, and 52.6% decrease respectively in comparison to the size detected at entering the trial. One patient showing PR in the control group achieved 13.4 cm3 (59%) decrease. Urination complaints ceased in 8 patients of the treated group, but none of the patients experienced changes in their complaints in the placebo group (p=0.0041). 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; Fishers Exact Test, p=0.034).
The cumulative time of DDW consumption of the retrospectively evaluated 91 patients was 139.2 years. The time period from the initial diagnosis to the end of the follow-up was 350.1 years. The median survival time (MST) of the 91 patients was 11.02 years although 46 of them (50.5%) had distant metastasis either before the start of the DDW treatment or after that. Due to the extremely low death rate (4 patients, 8.8%) in spite of the 157 years cumulative follow-up period in the population without distant metastasis, we could not calculate the MST. Investigating the patients with distant metastasis developed within one year after the diagnosis, the MST was 5.4 year (64.8 months) suggesting that the administration of DDW may had an effect resulting in longer MST comparing to other studies with progressive metastatic prostate cancer showing 15-20 months long MST. 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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