Early Assessment of Treatment Response Using Functional Diffusion Mapping

Overview

This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

Detailed Description

This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

Interventions

  • Procedure: Diffusion MRI

Arms, Groups and Cohorts

  • Experimental: Diffusion MRI Assessment
    • Men with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in diffusion MRI measurements
    • Time Frame: Baseline, 2 weeks and 9-12 weeks
    • Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.

Secondary Measures

  • Change in units/L of CK18Asp306
    • Time Frame: Baseline, 2 weeks and 9-12 weeks
    • Levels of CK18Asp396 can be measured in serum using a commercially available ELISA (Enzyme-linked Immunosorbent Assay). Changes in serum CK18Asp396 (a marker of apoptosis) will be correlated with functional diffusion maps and treatment response.
  • Change in levels of bone turnover markers
    • Time Frame: Baseline, 2 weeks and 9-12 weeks
    • Correlate the changes in biochemical markers of bone turnover, such as N-telopeptide and bone-specific alkaline phosphatase, with functional diffusion maps and treatment response.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of prostate cancer.
  • Evidence of metastatic disease by bone scan.
  • Patients must be initiating systemic therapy for metastatic disease.
  • New D2 disease beginning therapy with androgen deprivation.
  • CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
  • Patients must be willing to provide the blood samples for the correlative markers.
  • Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes.
  • Life expectancy of 12 weeks or greater.
  • All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

  • Contraindication to MRI imaging.
  • Patients who require sedation with general anesthesia to undergo MRI imaging.
  • Weight greater than 275 pounds.

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan Rogel Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maha Hussain, MD, FACP, Principal Investigator, University of Michigan

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.