Metastatic Cancer, Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases
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.
Interventions
DRUGparicalcitol
OTHERimmunoenzyme technique
OTHERlaboratory biomarker analysis
PROCEDUREdual x-ray absorptometry
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 16 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Paricalcitol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 81.8 years STANDARD_DEVIATION 2.3 |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
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
Population: This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.