NCT00634582

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 10, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

March 12, 2008

Results QC Date

November 22, 2013

Last Update Submit

July 3, 2018

Conditions

Metastatic CancerProstate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancerbone metastases

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

paricalcitolDRUG
immunoenzyme techniqueOTHER
laboratory biomarker analysisOTHER
dual x-ray absorptometryPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • hydroxyvitamin D (25-OHD) ≥ 20 ng/mL
  • ,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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisProstatic Neoplasms

Interventions

paricalcitolImmunoenzyme TechniquesAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe TechniquesRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, Analytical

Results Point of Contact

Title
Gary Schwartz, PhD
Organization
Comprehensive Cancer Center of Wake Forest Univeresity
gschwart@wakehealth.edu
336-716-7446

Study Officials

  • Gary G. Schwartz, MD, PhD, MPH

    Wake Forest University Health Sciences

    STUDY CHAIR

  • Mebea Aklilu, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 13, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

June 1, 2015

Last Updated

July 6, 2018

Results First Posted

January 10, 2014

Record last verified: 2018-07

Locations

US(1)