MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00165386
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Magnetic Resonance Imaging; Procedure: Bone Marrow Biopsy	N/A

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".

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: MRI-guided Bone Marrow Biopsies of Advanced CaP Patients
• Study Start Date: Jul 1, 2001
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00165386
• Other Study ID Numbers: 01-108
• First Posted: Sep 14, 2005
• Last Update Posted: Dec 9, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: MRI-guided bone marrow biopsy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Dec 9, 2009