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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01553838
First received: March 1, 2012
Last updated: August 18, 2014
Last verified: March 2012
  Purpose

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 Intervention
Prostate Cancer
Device: MRI guided prostate biopsy and TRUS guided biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Prostate cancer detection rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 185
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01553838     History of Changes
Other Study ID Numbers: 002
Study First Received: March 1, 2012
Last Updated: August 18, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014