We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383487
Recruitment Status : Terminated (Extreme toxicity)
First Posted : October 3, 2006
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

Brief Summary:
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 Intervention/treatment Phase
Prostatic Neoplasms Prostate Cancer Drug: Calcitriol Drug: Naproxen-n-butyl nitrate Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Study Start Date : March 2005
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Intervention Details:
    Drug: Calcitriol
    0.5 micrograms/kilogram q weekly
    Other Names:
    • 1,25-Dihydroxycholecalciferol
    • 1,25-dihydroxyvitamin D3
    Drug: Naproxen-n-butyl nitrate
    400 mg BID, oral
    Other Name: Naprosyn

Primary Outcome Measures :
  1. PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383487

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr. Sandy Srinivas Stanford University

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00383487     History of Changes
Other Study ID Numbers: PROS0021
95804 ( Other Identifier: Stanford University alternate IRB Number )
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents