MRI for Assessing Prostate Cancer Response

NCT01607008 | Active Not Recruiting

• 2 other identifiers: J11143NA_00067284
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam radiation therapy is one of the common methods to treat prostate cancer. Although radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic ratio. Those side effects are usually associated with the radiation damage of the normal tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the side effects of radiation treatment are often accessed after whole course of radiotherapy, which makes the early intervention difficult. The current research project is a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to access radiotherapy treatment response of prostate cancer during and right after radiotherapy. Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments for diagnostic purpose. This research project is to study the feasibility of using advanced MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes revealed from MRI can provide physicians early information on possible tumor recurrence and normal tissue toxicity, therefore, the early intervention may be possible to spare normal tissue and cure the patient. The project is designed to combine several different advanced MRI imaging techniques systematically to study tissue changes during radiotherapy, which has not been seen elsewhere to date. Another important goal of this research project is to study the feasibility of associating functional MRI with radiation treatment dose distribution. Tissue response during radiation treatment depends on dose. The functional MRI can provide more information than simple anatomic information. Mapping the functional MRI spatially and associating them with 3D dose distribution in radiation treatment planning system is one important step to quantitative assess the relationship between radiation treatment and tissue changes due to the radiation.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• MRI use to predict treatment response

  To study the feasibility of using magnetic resonance imaging (MRI) to predict treatment response in patients with prostate cancer undergoing radiation therapy. The anatomical, functional, and location changes in tumor or normal tissues during the radiation will be assessed and correlated with MRI data and treatment dose. Hypothesis one: Functional or anatomical MRI signal changes during the radiotherapy can be used as predictors to assess treatment response. We anticipate observing dose dependent MRI signal changes during the radiation treatment.

  2 months

Secondary Outcomes (1)

• Evaluating MRI use to predict functional radiation treatment dose distribution

  2 months

Study Arms (1)

MRI imaging

OTHER

Use of MRI imaging in conjunction with standard radiation treatment

Other: MRI imaging

Interventions

MRI imaging OTHER

3 total MRI imaging studies: 1. pre standard radiation treatment 2. during standard radiation treatment 3. post standard radiation treatment

MRI imaging

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed prostate cancer
• Plan to undergo external radiation treatment of prostate cancer

You may not qualify if:

• Patients who cannot undergo an MRIs
• Patients who are allergic to gadolinium based contrast agent
• Patients who have cardiac pacemaker or other electronic or metal implant
• Patients who have chronic kidney disease

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Danny Song, M.D.

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: November 16, 2012
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)