NCT00165386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2001

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

4.5 years

First QC Date

September 9, 2005

Last Update Submit

December 7, 2009

Conditions

Prostate Cancer

Keywords

MRI-guided bone marrow biopsy

Outcome Measures

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.

Interventions

Magnetic Resonance ImagingPROCEDURE
Bone Marrow BiopsyPROCEDURE

Eligibility Criteria

Age30 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mary-Ellen Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2001

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

US(1)