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A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

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ClinicalTrials.gov Identifier: NCT01553838
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief Summary:
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MRI guided prostate biopsy and TRUS guided biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sequentially MRI guided and TRUS guided biopsy
Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy
Device: MRI guided prostate biopsy and TRUS guided biopsy
MRI guided prostate biopsy



Primary Outcome Measures :
  1. Prostate cancer detection rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PSA > 4.0 ng/ml
  • written informed consent
  • age >18

Exclusion Criteria:

  • patients with prostate cancer
  • patients with prior prostate biopsy
  • patients with contraindications against MRI or biopsy

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): NCT01553838


Locations
Germany
Department of Urology
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Christian Arsov, MD Department of Urology, University of Duesseldorf

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01553838     History of Changes
Other Study ID Numbers: 002
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: March 2012

Keywords provided by Heinrich-Heine University, Duesseldorf:
prostate biopsy
MRI guided biopsy
TRUS guided biopsy