Prostate Cancer

Assorted Experiences with Prostate Cancer

Male patient (65); on Dd-water from 10-30-1992

(South-Pest Hospital, Budapest, Hungary)

The patient was diagnosed with inoperable prostate tumor in October 1992. After the beginning of the cure he noted an improvement in urination problems and the PSA value decreased even prior to the start of the Fugerel treatment. After one month the tumor became impalpable and also operable, but the patient (a physician by profession) refused to undergo surgery. After drinking Dd-water for a year, the patient has been free of complaints for seven years.

Male patient (66); on Dd-water from 12-01-1994

(MJVÖ Hospital, Szeged, Hungary)

In September 1994 the tumor of the prostate caused total obstruction and metastases in the lymphatic glands. In October the PSA value was 83.4 ng/ml. Following Dd-water consumption,urination problems stopped within a short time. Two weeks after the start of the Dd-water cure, blood samples revealed a 0.99 ng/ml PSA value. This, however, was thought to be erroneous, therefore two weeks later it was repeated, and showed a value of 0.6 ng/ml. This value decreased by March 1995 to 0.23 ng/ml, whereas values measured in June 1996 and January 1997 were below the traceable level. The patient had, for the first time, been drinking Dd-water continuously for 9 months, and repeated the cure for 2–3 months in 1996.

Note: In the case of prostate tumor it is of great significance that by measuring PSA value, the potentially tumorous patient population can be defined. Based on our results so far, we are of the opinion that if we are able to diagnose the illness in its early phase, with the application of Dd-water this tumor type can be cured with great efficacy without the need for drug treatment throughout the patient’s whole life. It would be of great economic significance to test the male population above 50–60 for PSA value and to treat cancer patients with Dd-water. For the time being, the cheap test (some thousand forints/test) is followed by very expensive treatment (approx. USD 2000-3000/year/patient) which, in the majority of cases lasts throughout the entire life of the patient. Not even the United States of America can afford to provide preventive treatment for all men with tumor of the prostate, as this would cost about 100 billion dollars. The application of Dd-water would make the treatment followed by cheap scanning accessible to everyone.

Phase II. Clinical Trial
The existing clinical data can be divided into two main groups.

Fourty-two patients belong to the group had been treated in the double blind clinical trial (first group) and almost 900 patients belong to the second group, which covers the patients who consumed the DDW before and parallel with the clinical trial.

HYD's core product, Depletin®, is under phase II clinical investigation. The clinical trial that is a double-blind, placebo controlled and of 4 months duration involved 80 patients with prostate cancer in four oncology centers in Hungary. Patients received DDW as drinking water in addition to their conventional anti-cancer medication. The primary goal of the trial was to justify the efficacy and safety of DDW in prostate cancer patients. The interim evaluation (May 1997) of the phase II study, based on data for 42 patients, showed statistically significant reduction in prostate volume of those patients ingesting DDW versus placebo treated ones. In addition, no drug-related side-effects have been observed. The completed clinical trial involved 66 patients in four oncology centers. The final evaluation has been filed at the Hungarian Institute of Pharmacy.

Abstract / Interim evaluation

August 8, 1995 a human, phase II double blind clinical trial was initiated with the aim of studying the therapeutic effect of ingestion of water with reduced deuterium content in patients with prostatic tumour. Until performing the intermediate analysis (May, 1997) 42 patients were included, in 39 of which treatment was introduced (Safety Population, SP). Four of the patients were excluded from evaluation, consequently statistical analysis was performed with 35 (Intention-to-Treat Population, ITT) and 26 (Per Protocol Population, PP).

During the nearly two years of the clinical trial no serious undesirable event attributed to the agent or other undesirable event happened.

According to the study hypothesis the ratio of patients ranged as PR in the group containing the agent should exceed by at least 30 % that of the patients ranged as PR in the control group. This hypothesis established for the primary variable was verified during the study: at the fifth or sixth visit all the proportion of patients with improving efficacy was statistically significantly greater (5th visit: p=0.0096, 6th visit: p=0.021) in the treatment group.

The change of prostatic size significantly differs between the two groups: on one hand prostatic volume decreased at the 5% level of significance in the treatment group, while score values the control group can be regarded as unchanged, on the other hand prostatic size decreased in more patients at the 5 % level of significance (Armitage Exact Test: p=0.015, Fischer Exact Test: p=0.011).

This result is confirmed by the observations regarding urination problems, when it was ascertained, that at the 1% significance level more patients had a better judgment of the changes in the symptom in the group taking the agent (Armitage Exact Test: p=0.0009, Fischer Exact Test: p=0.0018).

Examining the survival of the patients, it was ascertained, that survival of the patients belonging to the group taking the agent was significantly longer (p=0.030).

The average score values derived from the scores introduced for measuring the changes of the symptoms showed also significant differences: in the ITT-group the averages of the weighted score of the two treatment groups differred from each other at the significance level of 1% (p=0.0045). In the PP-group the averages of the weighted score of the two treatment groups significantly differred from each other at the significance level of 5% (p=0.015).

Among laboratory results significant difference was found for gamma-GT and alcalic phosphatase (ALP): in the group taking the agent decrease, in the control group increase was experienced (gamma-GT: p=0.028, ALP: p=0.022).

According to the opinion of the physicians patients taking the agent tolerated the preparation received during the clinical trial significantly (p=0.024) better.

Abstract / Final evaluation

Double blind, placebo controlled Phase II clinical trial with prostate cancer, in compliance with GCP principles confirmed a significant difference between the control and treated groups with respect to the examined parameters that indicated the anti-tumour effect of the preparation.

At the time of the 5th and 6th visits, the ratio of patients showing an increased efficacy (PR) was significantly higher statistically (6th visit: p = 0.046) in the treated group.

Significantly more patients reported a positive change in symptoms in the treated group (exact Armitage-test: p = 0.0014).

The survival rate in the treated group was significantly higher (p = 0.034).

The conclusion from the results of the clinical trial can be drawn, that the decrease in the deuterium concentration in the patients organism caused by the water with reduced deuterium content (deuterium-depleted water, DDW) may be used as efficacious means in oncologic treatment.

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