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

Prostate Cancer Clinical Trial

Official title:

Proteases in Prostate Cancer Bone Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899665
• Other study ID #: CDR0000483773
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 10, 2014
• Start date: July 2001
• Est. completion date: January 2008

Study information

• Verified date: February 2014
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Anemia
• Metastatic Cancer
• Myelodysplastic Syndromes
• Neoplasm Metastasis
• Precancerous Condition
• Precancerous Conditions
• Preleukemia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• fluorescence in situ hybridization

• microarray analysis

• molecular diagnostic method

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• biopsy

• immunoscintigraphy

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression and activity of proteases and related molecules			No