Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer
March 11, 2019 updated by: Fergus Coakley, OHSU Knight Cancer Institute
Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy.
Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI.
MRI uses magnets to take pictures of the prostate and may be able to identify cancer.
Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy.
It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.
Study Overview
Status
Terminated
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.
II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.
III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.
IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.
OUTLINE:
Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
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
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [PSA] level and/or abnormal digital rectal examination)
- No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
- Patient willing to undergo scheduled standard of care TRUS guided biopsy
- Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health & Science University (OHSU)
- Laboratory values and anticoagulation management per consensus guidelines, including:
- International normalized ratio (INR) >= 1.5
- Platelets >= 50,000
Exclusion Criteria:
- Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
- Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
- Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
- Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
- Active urinary tract infection
- Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)
Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI.
Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI.
Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
|
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Other Names:
Given IV
Other Names:
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Other Names:
Undergo transrectal MRI-guided biopsy
Other Names:
Undergo TRUS-guided biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy
Time Frame: Up to 42 days (6 weeks)
|
The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated.
McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy.
Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
|
Up to 42 days (6 weeks)
|
|
Sensitivity of MRI-guided Biopsy
Time Frame: Up to 2 weeks after diagnostic MRI
|
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard.
For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated.
The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test.
To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
|
Up to 2 weeks after diagnostic MRI
|
|
Sensitivity of TRUS-guided Biopsy
Time Frame: Up to 2 weeks after MRI-guided biopsy
|
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard.
For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated.
The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test.
To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
|
Up to 2 weeks after MRI-guided biopsy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fergus Coakley, OHSU Knight Cancer Institute
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
May 1, 2015
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
February 10, 2017
Study Registration Dates
First Submitted
July 15, 2015
First Submitted That Met QC Criteria
July 15, 2015
First Posted (Estimate)
July 17, 2015
Study Record Updates
Last Update Posted (Actual)
April 3, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00010086 (Other Identifier: OHSU Knight Cancer Institute)
- P30CA069533 (U.S. NIH Grant/Contract)
- NCI-2015-00930 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SOL-13142-LM
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