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MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02131207
Recruitment Status : Terminated (Principal Investigator Left Institution)
First Posted : May 6, 2014
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Device: magnetic resonance imaging Procedure: prostate biopsy

Detailed Description:

PRIMARY OBJECTIVES:

I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).

SECONDARY OBJECTIVES:

I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.

IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.

V. Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.

OUTLINE:

Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.


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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Screening MRI for the Detection of Prostate Cancer
Actual Study Start Date : September 10, 2014
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diagnostic (MRI and biopsy)
Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy.
Device: magnetic resonance imaging
Undergo pelvic MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Procedure: prostate biopsy
Undergo prostate biopsy
Other Names:
  • biopsy of prostate
  • prostatic biopsy




Primary Outcome Measures :
  1. Increased detection of clinically significant prostate cancer [ Time Frame: Up to 1 year ]
    Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%


Secondary Outcome Measures :
  1. Detection of clinically significant prostate cancer using 3D T2 SPACE [ Time Frame: Up to 1 year ]
    Number of patients with positive prostate cancer detection using 3D T2 SPACE

  2. Detection of clinically significant prostate cancer using 3D T2 HASTE [ Time Frame: Up to 1 year ]
    Number of patients with positive prostate cancer detection using 3D T2 HASTE


Other Outcome Measures:
  1. Pathology specimen correlation with MRI findings [ Time Frame: Up to 1 year ]
    Statistical correlation of MRI findings with final pathology specimens in those patients who elect to be treated with radical prostatectomy for treatment of their biopsy detected prostate cancer with 0 showing no correlation and 1 showing perfect correlation between findings.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam
Criteria

Inclusion Criteria:

  • Abnormal prostate-specific antigen (PSA) blood test

    • > 2.5 ng/mL for men < 50 years (yrs) of age
    • > 3.5 ng/mL for men < 60 yrs of age
    • > 4.5 ng/mL for men < 70 yrs of age
  • Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
  • Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer

Exclusion Criteria:

  • Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
  • Contraindications to TRUS/prostate biopsy (BX)

    • Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder
    • Active urinary tract infection
    • Acute painful perianal disorder (i.e. rectal abscess)
  • Contraindications to MRI

    • Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
    • The presence of an implanted pacemaker or implanted defibrillator device
    • Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
    • Implanted medical device not described above that is not MRI-compatible
    • Known history of claustrophobia
  • Individuals with a short life expectancy (< 10 years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131207


Locations
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United States, Ohio
University Hospitals, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert Abouassaly Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02131207     History of Changes
Other Study ID Numbers: CASE6813
NCI-2014-00822 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6813 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases