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Imaging

MRI Scans for Prostate Cancer

N/A

Waitlist Available

Led By Tharakeswara K Bathala

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ > 8

Be older than 18 years old

Must not have

Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy

Patient is at low risk for metastasis with Gleason score at diagnosis < 8

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how effective magnetic resonance whole body diffusion-weighted imaging is at finding cancer that has spread to the bone or lymph nodes in participants with high-risk prostate cancer.

Who is the study for?

This trial is for individuals with high-risk prostate cancer, specifically those who have a PSA level over 20 ng/ml and/or a Gleason score of 8 or higher. Participants must be able to understand and sign consent. It's not for those on testosterone suppressing drugs, previous radiation therapy, low-risk patients (Gleason score < 8), or anyone who can't undergo MRI.

What is being tested?

The study is testing the effectiveness of magnetic resonance whole body diffusion-weighted imaging in detecting the spread of prostate cancer to bones or lymph nodes compared to traditional bone scans and CT scans.

What are the potential side effects?

Since this trial involves diagnostic procedures like MRIs rather than medications, side effects are minimal but may include discomfort from lying still during the scan or reactions if contrast agents are used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA level is over 20 ng/ml or my Gleason score is 8 or higher, indicating high-risk prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with hormone therapy or radiation for my condition.

Select...

My initial Gleason score for prostate cancer was below 8, indicating low risk of spreading.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of whole body magnetic resonance imaging (MRI)

Secondary study objectives

Detection of other types of metastases

Negative predictive value (NPV) of MRI, bone scan, and CT scan

Positive predictive value (PPV) of MRI, bone scan, and CT scan

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)Experimental Treatment4 Interventions

Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Scan

2015

Completed Phase 2

~50

Computed Tomography

2017

Completed Phase 2

~2790