Abbreviated Biparametric MRI (RSI + T2WI) for Prostate Cancer Detection: Correlation With Histopathology

September 24, 2025 updated by: M.D. Anderson Cancer Center

Multiparametric MRI of the prostate (mpMRI) plays an integral role in contemporary prostate cancer management. It involves the acquisition of both anatomical sequences (T1- and T2-weighted images) as well as 'functional' imaging sequences (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) imaging), the latter sequences being those which image water diffusivity and tissue perfusion, respectively. Advantages of mpMRI include ability to risk stratify patients prior to biopsy, enhanced detection of clinically significant cancer and reduced diagnosis of insignificant cancers, the identification of active surveillance candidates and improved local staging for subsequent surgical and radiotherapy planning. However, there are ongoing challenges encountered with prostate mpMRI in terms of patient acceptance, image acquisition technical challenges, interpretive expertise and cost.

These challenges have motivated recent investigations employing tailored MRI protocols, i.e. faster and less expensive MR exams that eliminate one or more aspects of current mpMRI technique considered redundant, while retaining the essential imaging parameters needed for equivalent diagnostic interpretation. Among these is non-contrast biparametric MRI, which involves anatomic T2 weighted images along with diffusion weighted images (DWI) as the only retained functional sequence. Both single center studies and meta analyses have demonstrated no added value for DCE compared to the combination of T2WI and DWI, Overall cancer detection rates have been found to be equivalent for bpMRI compared to mpMRI, independent of reader experience, with comparable efficacy to guide cognitive targeted, MRI-targeted and MRI-US fusion guided biopsy. Equivalence between bpMRI and mpMRI for cancer detection has also been corroborated in two recently published meta analyses. Based upon our institution's experience with prostate mpMRI, avoidance of gadolinium and DCE imaging would be associated with a 30 percent reduction in scan cost and 40 percent reduction in total time (i.e. scan time plus patient preparatory time).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

This is a prospective study of men presenting to MD Anderson with treatment naïve, histologically confirmed prostate cancer.

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. Results will be validated against histopathologic findings at prostatectomy as the reference standard.

We hypothesize that T2WI + RSI will detect more clinically significant prostate cancer foci (any Gleason grade group > 2) compared to mpMRI when one-to-one matching between imaging and prostatectomy findings is performed.

Secondary Objectives

-To perform a pilot study evaluating T2WI+RSI/US fusion guided biopsy compared to mpMRI/US fusion biopsy for the diagnosis of clinically significant cancer (any Gleason grade group > 2) in a cohort of patients scheduled for clinically indicated MRI/US fusion guided biopsy. In this pilot study, we hypothesize that RSI/US fusion guided biopsy will be non-inferior to mpMRI/US fusion guided biopsy in the detection of clinically significant prostate cancer.

Primary Objectives:

  • To acquire high frequency transrectal microultrasound data in patients undergoing clinically indicated MRI/US fusion guided biopsy.
  • To perform additional comparative analyses of mpMRI and RSI images, including analyzing variations in tumor contours between imaging data sets.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

-Inclusion Criteria:

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 (42)) with a clinical indication for prostate mpMRI for pre-treatment tumor detection and staging
  • Patients with anticipated clinical follow-up who are anticipated to undergo surgery at MD Anderson.

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 (42)) with a clinical indication for prostate mpMRI, who are to undergo target selection for fusion guided biopsy.
  • Patients who are anticipated to undergo fusion guided biopsy at MD Anderson.

Exclusion Criteria:

  • Patients who have already received androgen deprivation therapy or undergone prior surgery, radiotherapy or focal ablative therapies to the prostate
  • Patients whose weight exceeds 400 pounds
  • Patients allergic to gadolinium
  • Patients with pacemakers or other implantable devices or conditions that are a contraindication to MRI
  • Patients with conditions precluding MR imaging at 3T
  • Patients less than 18 years of age
  • Patients unable to provide informed consent
  • Patients unable to tolerate an endorectal coil
  • Patients who have undergone prostate biopsy less than 6 weeks prior to their MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI technique
restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.
Device: restriction spectrum imaging (RSI)
detect prostate cancer better than a standard-of-care MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Aradhana Venkatesan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0823
  • NCI-2021-09145 (Other Identifier: NCI CTRP-Clinical Trials Gov Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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