A 12 week, open label, phase I/IIa study using apatone for the treatment of prostate cancer patients who have failed standard therapy.
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.
Tareen
Basir
B
Summa Health System, Department of Urology, Akron, Ohio, USA. tareen@medicine.nodak.edu
Summers
Jack L
JL
Jamison
James M
JM
Neal
Deborah R
DR
McGuire
Karen
K
Gerson
Lowell
L
Diokno
Ananias
A
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*
D024483:Vitamin K 3; D001205:Ascorbic Acid