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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
restriction spectrum imaging (RSI)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

-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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI technique

Arm Description

restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
August 23, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05046782
Brief Title
Abbreviated Biparametric MRI (RSI + T2WI) for Prostate Cancer Detection: Correlation With Histopathology
Official Title
Abbreviated Biparametric MRI (RSI + T2WI) for Prostate Cancer Detection: Correlation With Histopathology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI technique
Arm Type
Experimental
Arm Description
restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.
Intervention Type
Device
Intervention Name(s)
restriction spectrum imaging (RSI)
Intervention Description
detect prostate cancer better than a standard-of-care MRI
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
-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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aradhana Venkatesan
Phone
713-563-8880
Email
avenkatesan@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aradhana Venkatesan
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aradhana Venkatesan
Phone
713-563-8880
Email
AVenkatesan@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Aradhana Venkatesan

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

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

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