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

NCT00899665 — Completed, 31 participants, Barbara Ann Karmanos Cancer Institute

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Proteases in Prostate Cancer Bone Metastasis

Registry	NCT00899665
Status	Completed
Study type	Observational
Enrollment	31 (Actual)
Sponsor	Barbara Ann Karmanos Cancer Institute (Other); collaborators: National Cancer Institute (NCI)
Conditions	Anemia, Metastatic Cancer, Myelodysplastic Syndromes, Precancerous Condition, Prostate Cancer
Interventions	fluorescence in situ hybridization, microarray analysis, molecular diagnostic method, immunohistochemistry staining method, laboratory biomarker analysis, biopsy, immunoscintigraphy (Genetic, other, procedure)
Dates	start 2001-07-01, primary completion 2006-09-01, completion 2008-01-01, first posted 2009-05-12, last updated 2014-02-11
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

fluorescence in situ hybridization (Genetic)
microarray analysis (Genetic)
molecular diagnostic method (Genetic)
immunohistochemistry staining method (Other)
laboratory biomarker analysis (Other)
biopsy (Procedure)
immunoscintigraphy (Procedure)

+Outcome measures

Primary outcomes

Expression and activity of proteases and related molecules

+Eligibility

Sex: Male, ages: 40 Years to any

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

+Locations (1)

Facility	City	Country	Status
Barbara Ann Karmanos Cancer Institute	Detroit, Michigan	United States

+Investigators

Michael L. Cher, MD, Study chair, Barbara Ann Karmanos Cancer Institute

+Funding

NIH grants: P30CA022453