Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer
- To explore the relationship between paricalcitol therapy and markers of bone formation
in patients with androgen-refractory, advanced prostate cancer with bone metastases.
- To explore the relationship between paricalcitol therapy and markers of bone resorption
in these patients.
OUTLINE: Patients receive oral paricalcitol once daily for 10 weeks in the absence of
Patients undergo blood sample collection periodically to determine markers of bone formation
and resorption by ELISA; parathyroid hormone (PTH) levels by immunometric assay;
prostate-specific antigen (PSA) levels by immunoassay; and 25-hydroxyvitamin D and
1,25(OH)_2D levels by radioimmunoassay.
Patients also undergo a bone densitometry (DEXA scan) at baseline and at 10 weeks to assess
changes in bone strength.
Quality of life is assessed prior to, during, and after completion of treatment.
Questionnaires include the Pain Inventory, the Brief Pain Inventory, the Functional
Assessment of Cancer Therapy-G (FACT-G), and the Analgesic Use Diary (Narcotic Pain
After completion of study treatment, patients are followed every 6 months for 1 year.
Allocation: Non-Randomized, Primary Purpose: Treatment
Biochemical markers (i.e., serum parathyroid hormone [PTH], bone-specific alkaline phosphatase, and osteocalcin) that are surrogates for fracture risk and are associated with increased bone pain, morbidity, and mortality from prostate cancer
Gary G. Schwartz, MD, PhD, MPH
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|