Int J Med Sci 2008; 5(2):62-67. doi:10.7150/ijms.5.62

Research Paper

A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

Basir Tareen1, Jack L. Summers1, James M. Jamison1, Deborah R. Neal1, Karen McGuire1, Lowell Gerson1, Ananias Diokno 2

1. Summa Health System, Department of Urology, Akron, Ohio, USA
2. William Beaumont Hospital, Department of Urology, Royal Oak, Michigan, USA

Abstract

Purpose: To evaluate the safety and efficacy of oral Apatone® (Vitamin C and Vitamin K3) administration in the treatment of prostate cancer in patients who failed standard therapy.

Materials and Methods: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day) for a period of 12 weeks. Prostate Specific Antigen (PSA) levels, PSA velocity (PSAV) and PSA doubling times (PSADT) were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients.

Results: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p ≤ 0.05). There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment.

Conclusion: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.

Keywords: Prostate, Prostate neoplasms, ascorbic acid, menadione, Vitamin K3, Apatone, Cancer

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How to cite this article:
Tareen B, Summers JL, Jamison JM, Neal DR, McGuire K, Gerson L, Diokno A. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy. Int J Med Sci 2008; 5(2):62-67. doi:10.7150/ijms.5.62. Available from http://www.medsci.org/v05p0062.htm