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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00899665
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 11, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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 or disease Intervention/treatment
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

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 31 participants
Official Title: Proteases in Prostate Cancer Bone Metastasis
Study Start Date : July 2001
Actual Primary Completion Date : September 2006
Actual Study Completion Date : January 2008

Primary Outcome Measures :
  1. Expression and activity of proteases and related molecules

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • See Disease Characteristics


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00899665

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48076
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Michael L. Cher, MD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00899665    
Other Study ID Numbers: CDR0000483773
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014
Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IV prostate cancer
bone metastases
monoclonal gammopathy of undetermined significance
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Precancerous Conditions
Myelodysplastic Syndromes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hematologic Diseases
Bone Marrow Diseases