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| Sponsors and Collaborators: |
Stanford University Novacea |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00383487 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Drug: DN-101 Drug: Naproxen (Naprosyn) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Must give written informed consent
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Dr. Sandy Srinivas | Stanford University |
More Information
| Responsible Party: | Stanford University School of Medicine ( Sandy Srinivas, Principal Investigator ) |
| Study ID Numbers: | PROS0021, 95804, NCT00383487, PROS0021 |
| Study First Received: | September 29, 2006 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00383487 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Inflammatory Agents Naproxen Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Urogenital Neoplasms Genital Diseases, Male Recurrence |
Calcitriol Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Prostatic Neoplasms |
|
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Gout Suppressants Pharmacologic Actions |
Neoplasms Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Prostatic Neoplasms |
