Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.
PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: dual x-ray absorptometry
Procedure: quality-of-life assessment
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer|
- 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 [ Designated as safety issue: No ]
- Markers of bone resorption (i.e., tartrate resistant acid phosphatase [TRAP], cross-linked C-telopeptide of type I collagen [ICPT], and osteoprotegerin [OPG]) [ Designated as safety issue: No ]
- Reduction in self-reported pain [ Designated as safety issue: No ]
- Decreased analgesic use [ Designated as safety issue: No ]
- Maintaining or improving health-related quality of life [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- 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 unacceptable toxicity.
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 Medication Logbook).
After completion of study treatment, patients are followed every 6 months for 1 year.
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Gary G. Schwartz, MD, PhD, MPH||Comprehensive Cancer Center of Wake Forest University|
|Principal Investigator:||Mebea Aklilu, MD||Comprehensive Cancer Center of Wake Forest University|