Clinical trial · Interventional
Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer
NCT00634582CI-TRIAL-00033646terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dual x-ray absorptometry | Procedure | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| paricalcitol | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion: * Histologically or cytologically confirmed advanced adenocarcinoma of the prostate \- Radiographically proven bone metastasis from prostate cancer * Androgen refractory disease (including anti-androgen withdrawal) * Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values \> 70 pg/mL, 14 days apart * ECOG performance status 0-2 * Leukocytes ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelets ≥ 100,000/μL * Total bilirubin normal * AST/ALT ≤ 2.5 times upper limit of normal * Creatinine clearance ≥ 60 mL/min * Calcium normal * 25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL * 1,25(OH)\_2D normal * Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy * More than 8 weeks since prior bisphosphonates * More than 2 weeks since prior palliative radiotherapy * More than 4 weeks since other prior therapy * No more than one prior taxane-containing chemotherapy regimen for metastatic disease * Multiple lines of prior therapy with hormonal agents allowed * Concurrent corticosteroids allowed provided the dose remains stable during the study period Exclusion: * Underlying metabolic bone disease or vitamin D deficiency * History of hypercalcemia * Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance * Concurrent ergocalciferol supplementation * Concurrent chemotherapy or hormonal therapy * Concurrent investigational or commercial agents for the malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.