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MRI Technique
Abbreviated Biparametric MRI for Prostate Cancer
Phase 2
Waitlist Available
Led By Aradhana Venkatesan
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
Secondary Objective Cohort: Treatment naïve patients with histologically confirmed intermediate risk prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm) with a clinical indication for prostate mpMRI, who are to undergo target selection for fusion guided biopsy
Primary Objective Cohort: Treatment naïve patients with histologically confirmed clinically significant prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm) with a clinical indication for prostate mpMRI for pre-treatment tumor detection and staging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial assesses whether a tailored MRI protocol that eliminates one or more aspects of current mpMRI technique is just as effective as the standard mpMRI protocol for cancer detection.
Who is the study for?
This trial is for treatment-naive patients with clinically significant prostate cancer (Gleason score > 3+4, cancer core length > 4mm) needing an MRI before treatment or biopsy. Excluded are those with pacemakers, conditions preventing MR imaging at 3T, under age 18, unable to use an endorectal coil, prior androgen therapy or prostate treatments, over 400 pounds weight, unable to consent or recent biopsy.Check my eligibility
What is being tested?
The study tests a simplified MRI method called biparametric MRI (RSI + T2WI), which could be faster and cheaper than the standard multiparametric MRI by omitting certain sequences like DCE imaging. It aims to see if this simpler method can still effectively detect and stage prostate cancer.See study design
What are the potential side effects?
Since the intervention involves only non-contrast biparametric MRI scanning without gadolinium-based contrast agents used in typical mpMRI scans, there are minimal side effects expected other than those associated with standard MRIs such as discomfort from lying still.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have intermediate risk prostate cancer and have not received any treatment yet.
Select...
I have significant prostate cancer (Gleason score > 3+4) and need an mpMRI for staging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective of this study is to compare the diagnostic accuracy of T2 weighted imaging (T2WI) and restriction spectrum imaging (RSI) (T2WI + RSI) to that of multiparametric MRI (mpMRI), for the detection of individual prostate cancer foci.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI techniqueExperimental Treatment1 Intervention
restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,786,914 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,438 Patients Enrolled for Prostate Cancer
Aradhana VenkatesanPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments like hormone therapy or surgery for prostate cancer.I had a prostate biopsy less than 6 weeks before my MRI.I am expected to have a biopsy guided by fusion imaging at MD Anderson.I have intermediate risk prostate cancer and have not received any treatment yet.I am under 18 years old.I am expected to have surgery at MD Anderson and will be followed up clinically.I am unable to understand and give consent for treatment.I have significant prostate cancer (Gleason score > 3+4) and need an mpMRI for staging.
Research Study Groups:
This trial has the following groups:- Group 1: MRI technique
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted presently for this experiment?
"Information listed on clinicaltrials.gov reveals that this medical trial is no longer accepting patients for its study, as the recruitment period began on November 30th 2022 and ended October 4th of the same year. However, there are still 1320 other trials actively recruiting participants at present."
Answered by AI
Has the FDA granted authorization to utilize restriction spectrum imaging (RSI)?
"Our assessment of restriction spectrum imaging (RSI) safety is a 2 due to the Phase 2 status, demonstrating limited data supporting its efficacy but some evidence that it can be safe in certain scenarios."
Answered by AI
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