Int J Med Sci 2008; 5(2):62-67. doi:10.7150/ijms.5.62
A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy
1. Summa Health System, Department of Urology, Akron, Ohio, USA
2. William Beaumont Hospital, Department of Urology, Royal Oak, Michigan, USA
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
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