Early Assessment of Treatment Response Using Functional Diffusion Mapping

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Diffusion MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02064283

HUM00009498 (Other Identifier)

UMCC 2006.111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Diffusion MRI Assessment

Experimental group

Description:

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.

Treatment:

Procedure: Diffusion MRI