Glycosole Trial
in Mexico
To:[email protected]
Subject: Glucuronide

One of these two Mexican trials for prostate cancer says in a brief report: "there is evidence of lowering of PSA in three patients."

In this trial at Instituto Nacional de Cancerologia, Tlalpan, Mexico City 6 patients were enrolled in a "Pilot protocol for the adminstration of Glucuronide 4 Hydroxianisole (PMPG) to patients with advanced prostate cancer refractory to hormonal therapy."

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Of these 6 patients, 1 died within about a week of starting treatment:

Patient 4 - 923183, man of 60 years of age. Karnofsky [performance status] of 70%. Began treatment last week of July 1994, with PSA 422 ng/ml. Passed away Aug 2, 1994.

One declined markedly in overall health (Karnofsy performance status) during one month on the drug, although his PSA (extremely high) did not rise much. He dropped from the study, and they lost track of him:

Patient 6 - 933564, man of 77 years of age. Karnofsky of 50%. Began treatment July 26, 1994. PSA of 1407 ng/ml. Last visit August 26, 1994. Karnofsky of 20% and PSA of 1425 ng/ml. Foreign patient, lost. ("Paciente foraneo, actualmente perdido.")

Another man got sicker within two months, his PSA tripling and his performance status cut to minimal:

Patient 3 - 882802, man of 62 years of age. Karnofsky of 60%. Began treatment in August 1994 with PSA 140 ng/ml. Final visit 3 October 1994, I observed - PSA 400 ng./ml. Karnofsy of 20%.

That leaves the 3 patients "with evidence of lowering PSA." The response of 1 of these patients at first sight looks almost miraculous:

Patient 5 - 942726, man of 70 years of age. Karnofsky of 75%. Began treatment November 23, 1994 with PSA of 1863 ng/ml. Final visit 10 January 1995 with PSA of 2.2 ng/ml. Karnofsky 90%.

But this patient really cannot be counted as responding to Dr. Rubin's drug at all, for according to the investigator:

This patient received orchiectomy ["I performed an orchiectomy on this patient"] in September 1994.

This is strange -- two months before enrolling in a study for hormone refractory prostate cancer, this patient was judged a candidate for surgical castration. The investigator himself did the surgery -- and in noting the fact evidently implies that the PSA drop could have been caused by the orchiectomy. Yet still the invesitigator counts this patient as one who showed "lowering of PSA."

There remain 2 patients who may have benefitted, the first for one month, the second for longer:

Patient 1. - 932892, man of 69 years of age. Karnofsky [performance status level] of 80%. Began treatment in October 1994 with PSA of 453 ng-ml. Final visit November 20, 1994, I observed lowering of PSA to 302 ng/ml.

Patient 2 - 892545, man of 73 years of age. Karnofsky of 70%. Began treatment October 1994 with PSA of 1945 ng/ml. Final visit January 13, 1995, I observed lowering of PSA to 1561 ng/ml.

Unfortunately nothing is reported about any measurements aimed at assessing tumor shrinkage. No MRI or bone scan tests are reported, if done. This falls short of typical standards and even of the new US Food and Drug Adminstration FDA initiatives for speeding approval of new cancer therapies. The FDA hopes to "shorten approval times for cancer treatments by recognizing that tumor shrinkage is often an early indicator of a treatment's effectiveness." See:
Cancer Therapies: Accelerating Approval and Expanding Access

Publications by David Rubin, M.D.

Rubin DM, Rubin EJ. A minimal toxicity approach to cancer therapy: possible role of beta-glucuronidase. Med Hypotheses 1980 Jan;6(1):85-92

Rubin D. Free glucuronic acid in urine as estimate of tumor load. (letter) Clin Chem 1979 Oct;25(10):1867-1868

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