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

Stopped early · Phase 2

Conditions studied: Prostatic Neoplasms, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00383487

Run by

Stanford University

People needed

20

Starts

2005-03-01

Expected to finish

2007-07-01

Last updated by the study team

2013-01-28

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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