A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown
a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer.
Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing
prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to
believe that their combined effects on prostaglandins may be synergistic. Preliminary in
vitro assays in which calcitriol is given in combination with one of two different NSAIDs
(Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation
provides the rational for using them in combination for the treatment of prostate cancer. In
addition, it is hoped that any synergy noted would allow for the use of lower doses of
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Dr. Sandy Srinivas
United States: Institutional Review Board
|Stanford University School of Medicine||Stanford, California 94305-5317|