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Completed

NCT Number: NCT00165386

MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

  • 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".

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Bone Marrow Biopsy

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

MRI-guided Bone Marrow Biopsies of Advanced CaP Patients

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 9, 2009

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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