A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00383487
Recruitment Status :
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
Condition or disease
Prostatic NeoplasmsProstate Cancer
Drug: CalcitriolDrug: Naproxen-n-butyl nitrate
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 NSAIDs.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Must give written informed consent
Histologically confirmed adenocarcinoma of the prostate
Biochemical relapse after primary radiation therapy or surgery
Normal testosterone levels
3 rising PSA after nadir, with interval between PSA determinations > 2 weeks