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MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging

Bone Marrow Biopsy

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring MRI-guided bone marrow biopsy

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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: Devices incompatible to MR studies (e.g. pacemakers, ear implants, etc.)

Sites / Locations

Dana-Farber Cancer Institute

Outcomes

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.

Full Information

NCT ID

NCT00165386

First Posted

September 9, 2005

Last Updated

December 7, 2009

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00165386

Brief Title

MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

Official Title

MRI-guided Bone Marrow Biopsies of Advanced CaP Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

July 2001 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

5. Study Description

Brief Summary

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.

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

MRI-guided bone marrow biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Intervention Type

Procedure

Intervention Name(s)

Bone Marrow Biopsy

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary-Ellen Taplin, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

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