Early Assessment of Treatment Response Using Functional Diffusion Mapping

NCT02064283 | Completed DMC

• 2 other identifiers: UMCC 2006.111HUM00009498
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in diffusion MRI measurements

  Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.

  Baseline, 2 weeks and 9-12 weeks

Secondary Outcomes (2)

• Change in units/L of CK18Asp306

  Baseline, 2 weeks and 9-12 weeks

• Change in levels of bone turnover markers

  Baseline, 2 weeks and 9-12 weeks

Study Arms (1)

Diffusion MRI Assessment

EXPERIMENTAL

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.

Procedure: Diffusion MRI

Interventions

Diffusion MRI PROCEDURE

Diffusion MRI Assessment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Brisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015.

  PMID: 25859981 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Maha Hussain, MD, FACP

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: May 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)