Official Title: “A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

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.

Intervention(s) in this Clinical Trial

• Drug: DN-101
• Drug: Naproxen (Naprosyn)

Primary Measures

• PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.

Secondary Measures

• Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.

• Inclusion Criteria:- 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 Exclusion
• Criteria:- Local recurrence by CT scan
• Distant metastases by bone scan
• Hypercalcemia
• Nephrolithiasis
• Renal insufficiency (serum creatinine > 1.8 mg/dl)
• Pancreatitis
• History of ulcer or gastrointestinal bleeding
• More than 6 months of hormone ablation therapy
• Concurrent therapy for prostate cancer
• Uncontrolled HTN
• H/O MI, CVA, TIA
• Known coronary disease/cerebrovascular disease
• Platelet counts <50
• Patients on anticoagulants
• Patients on lithium

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stanford University

Overall Clinical Trial Officials and Contacts

Dr. Sandy Srinivas Principal Investigator Stanford University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00383487

Study ID Number: PROS0021

ClinicalTrials.gov Identifier: NCT00383487

Health Authority: United States: Institutional Review Board