MRI-Guided Bone Marrow Biopsies of Prostate Cancer Patients - Full Text View

Purpose

The purpose of this study is to target lesions of the prostate in the bone and to biopsy these lesions using MRI to identify the areas.

Condition	Intervention
Prostate Cancer	Procedure: Magnetic Resonance Imaging Procedure: Bone Marrow Biopsy

MedlinePlus related topics:

Cancer MRI Scans Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Official Title:	MRI-Guided Bone Marrow Biopsies of Advanced CaP Patients

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To compare the yield of detecting metastatic prostate cancer tissue using MRI-guided bone marrow needle biopsies to that of historical controls obtained through unguided biopsies.

Secondary Outcome Measures:

To evaluate the sensitivity of radiographic bone marrow changes detected by MRI for prostate cancer, as determined by the pathologic findings from bone marrow biopsy.

Estimated Enrollment:	20
Study Start Date:	July 2001
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

This study involves a one-time, MRI-guided bone marrow biopsy. Prior to this procedure, patients will need to have a bone scan performed within the last three months and a PSA blood test drawn within one month of registration to the study.
Patients are also required to participate in the DFCI research study "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer".

Eligibility

Criteria

Inclusion Criteria:

Histologic diagnosis of prostate cancer
Bone scan consistent with or suspicious of metastatic prostate cancer within last three months
Platelet count > 50,000/ul
PT and aPTT < 1.5 x control
At least one week removed from taking aspirin or coumadin
Currently participating in protocol "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer"

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165386

Locations


United States, Massachusetts
	Dana-Farber Cancer Institute
	Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators


Principal Investigator:	Mary-Ellen Taplin, MD	Dana-Farber Cancer Institute

More Information

Study ID Numbers:	01-108
First Received:	September 9, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00165386
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

MRI-guided bone marrow biopsy

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165386