Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
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|ClinicalTrials.gov Identifier: NCT00634582|
Recruitment Status : Terminated (slow accrual)
First Posted : March 13, 2008
Results First Posted : January 10, 2014
Last Update Posted : August 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||June 2015|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|