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Trial record 40 of 333 for:    prostate cancer AND MRI | ( Map: United States )

Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.

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ClinicalTrials.gov Identifier: NCT01964638
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Samir Taneja, MD, NYU Langone Health

Brief Summary:
This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Targeted Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Targeted Biopsy
Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.
Procedure: Targeted Biopsy



Primary Outcome Measures :
  1. Evaluation of rates of prostate cancer diagnosis [ Time Frame: One week after biopsy ]
    The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.


Secondary Outcome Measures :
  1. Evaluation of Rate of cancer diagnosis using targeted biopsy [ Time Frame: One week after biopsy ]
    The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.



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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
Criteria

Inclusion Criteria:

  • No previous diagnosis of adenocarcinoma of the prostate
  • No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
  • Active urinary tract infection

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Prior androgen deprivation therapy
  • Evidence urinary tract infection or significant urinary retention
  • Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
  • Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

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): NCT01964638


Locations
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United States, New York
NYU Smilow Prostate Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Samr S Taneja, MD Co-Director, Smilow Comprehensive Prostate Cancer Center

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Responsible Party: Samir Taneja, MD, Co-Director, Smilow Comprehensive Prostate Cancer Center, NYU Langone Health
ClinicalTrials.gov Identifier: NCT01964638     History of Changes
Other Study ID Numbers: S12-01613
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Samir Taneja, MD, NYU Langone Health:
Prostate Cancer
Prostate Biopsy
Targeted Biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases