Spots Global Cancer Trial Database for Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases. Secondary * 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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