Proteases in Patients With Prostate Cancer That Has Spread to the Bone

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00899665
First received: May 9, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in the laboratory may help the study of cancer.

PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in patients with prostate cancer that has spread to the bone with patients who do not have cancer that has spread to the bone.


Condition Intervention
Anemia
Metastatic Cancer
Myelodysplastic Syndromes
Precancerous Condition
Prostate Cancer
Genetic: fluorescence in situ hybridization
Genetic: microarray analysis
Genetic: molecular diagnostic method
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: immunoscintigraphy

Study Type: Observational
Official Title: Proteases in Prostate Cancer Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Expression and activity of proteases and related molecules [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: July 2001
Study Completion Date: January 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Examine the roles of proteases and protease-associated molecules in bone metastases in patients with metastatic prostate cancer.

OUTLINE: Patients undergo bone marrow aspiration and core bone biopsies. Tissues are analyzed by immunohistochemistry methods, in situ hybridization assays, gelatin zymography and/or Western blot analysis, and gene profiling analysis in order to visualize and quantitate protease or protease-related levels.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of metastatic prostate cancer

      • Patients with documented bone metastases on radiologic imaging studies must undergo bone marrow biopsy
    • Male patients ≥ 50 years of age without cancer who are scheduled to undergo bone biopsy for other clinically indicated reasons, including any of the following:

      • Myelodysplasia
      • Anemia
      • Monoclonal gammopathy of undetermined significance
    • Male or female patients ≥ 40 years of age without metastatic bone cancer who are scheduled to undergo an orthopedic procedure involving removal of bone specimen

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899665

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48076
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Michael L. Cher, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00899665     History of Changes
Other Study ID Numbers: CDR0000483773, P30CA022453, WSU-D-2111, WSU-12-35-99(M02)
Study First Received: May 9, 2009
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IV prostate cancer
bone metastases
anemia
monoclonal gammopathy of undetermined significance
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Precancerous Conditions
Prostatic Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 14, 2014