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A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy
oleh: Basir Tareen, Jack L. Summers, James M. Jamison, Deborah R. Neal, Karen McGuire, Lowell Gerson, Ananias Diokno
| Format: | Article |
|---|---|
| Diterbitkan: | Ivyspring International Publisher 2008-01-01 |
Deskripsi
<p><b>Purpose</b>: To evaluate the safety and efficacy of oral Apatone<b><sup>®</sup></b> (Vitamin C and Vitamin K<sub>3</sub>) administration in the treatment of prostate cancer in patients who failed standard therapy.</p> <p><b>Materials and Methods</b>: 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 VK<sub>3</sub> 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<b>. </b>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.</p> <p><b>Results</b>: 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.</p> <p><b>Conclusion</b>: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.</p>