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 Mar 24;5(2):62-7. doi: 10.7150/ijms.5.62.

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 < or = 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: Apatone; Cancer; Prostate; Prostate neoplasms; Vitamin K3; ascorbic acid; menadione.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Ascorbic Acid / administration & dosage
  • Ascorbic Acid / therapeutic use*
  • Drug Therapy, Combination
  • Humans
  • Male
  • Middle Aged
  • Prostatic Neoplasms / drug therapy*
  • Salvage Therapy
  • Vitamin K 3 / administration & dosage
  • Vitamin K 3 / therapeutic use*

Substances

  • Vitamin K 3
  • Ascorbic Acid