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Completed

NCT Number: NCT00899665

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

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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Key information

Conditions

Anemia Blood Protein Disorders Bone Marrow Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Male Urogenital Diseases Metastatic Cancer Monoclonal Gammopathy of Undetermined Significance Myelodysplastic Syndromes Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Condition Precancerous Conditions Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48076, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorescence in situ hybridization

Genetic

microarray analysis

Genetic

molecular diagnostic method

Genetic

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Biopsy

Procedure

immunoscintigraphy

Procedure

Primary outcomes

  1. Expression and activity of proteases and related molecules

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Proteases in Prostate Cancer Bone Metastasis

Important dates

Study start
2001
Primary completion
2006
Study completion
2008
First posted
May 12, 2009
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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