title: A 12 week, open label, phase I/IIa study using apatone for the treatment of prostate cancer patients who have failed standard therapy.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.
authors.affiliation: Summa Health System, Department of Urology, Akron, Ohio, USA. tareen@medicine.nodak.edu
authors.forename: Basir
authors.initials: B
authors.lastname: Tareen
authors.forename: Jack L
authors.initials: JL
authors.lastname: Summers
authors.forename: James M
authors.initials: JM
authors.lastname: Jamison
authors.forename: Deborah R
authors.initials: DR
authors.lastname: Neal
authors.forename: Karen
authors.initials: K
authors.lastname: McGuire
authors.forename: Lowell
authors.initials: L
authors.lastname: Gerson
authors.forename: Ananias
authors.initials: A
authors.lastname: Diokno
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001205:Ascorbic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016879:Salvage Therapy; D024483:Vitamin K 3 / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D024483:Vitamin K 3; D001205:Ascorbic Acid