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

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Novacea
• Treatments: Calcitriol; Dihydroxycholecalciferols; Naproxen; Naproxen-n-butyl nitrate

Criteria

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