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.
|Metastatic Cancer Prostate Cancer||Drug: paricalcitol Other: immunoenzyme technique Other: laboratory biomarker analysis Procedure: dual x-ray absorptometry Procedure: quality-of-life assessment||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 [ Time Frame: 16 weeks ]
|Study Start Date:||January 2009|
|Study Completion Date:||June 2015|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634582
|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||Wake Forest University Health Sciences|
|Principal Investigator:||Mebea Aklilu, MD||Wake Forest University Health Sciences|