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Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02501759
Recruitment Status : Terminated (Low enrollment and funding loss.)
First Posted : July 17, 2015
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Medical Research Foundation, Oregon
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fergus Coakley, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 17, 2015
Results First Submitted Date  ICMJE March 11, 2019
Results First Posted Date  ICMJE April 3, 2019
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02501759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer
Official Title  ICMJE Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Health Status Unknown
  • Prostate Carcinoma
Intervention  ICMJE
  • Procedure: 3 Tesla Magnetic Resonance Imaging
    Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
    Other Names:
    • 3 Tesla MRI
    • 3T MRI
  • Radiation: Gadodiamide
    Given IV
    Other Names:
    • DV 7572
    • Gadolinium-DTPA-BMA
    • Gd-DTPA-BMA
    • HSDB 7547
    • OmniScan
  • Procedure: Multiparametric Magnetic Resonance Imaging
    Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
    Other Name: Multiparametric MRI
  • Procedure: Transrectal Biopsy
    Undergo transrectal MRI-guided biopsy
    Other Name: Transrectal Prostate Biopsy
  • Procedure: Ultrasound-Guided Prostate Biopsy
    Undergo TRUS-guided biopsy
Study Arms  ICMJE 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.
Interventions:
  • Procedure: 3 Tesla Magnetic Resonance Imaging
  • Radiation: Gadodiamide
  • Procedure: Multiparametric Magnetic Resonance Imaging
  • Procedure: Transrectal Biopsy
  • Procedure: Ultrasound-Guided Prostate Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 17, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
512
Actual Study Completion Date  ICMJE February 10, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02501759
Other Study ID Numbers  ICMJE IRB00010086
NCI-2015-00930 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SOL-13142-LM
IRB00010086 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fergus Coakley, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE
  • Medical Research Foundation, Oregon
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Fergus Coakley OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP