NCT01553838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 19, 2014

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

March 1, 2012

Last Update Submit

August 18, 2014

Conditions

Prostate Cancer

Keywords

prostate biopsyMRI guided biopsyTRUS guided biopsy

Outcome Measures

Primary Outcomes (1)

  • Prostate cancer detection rate

    3 years

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a measure of Safety and Tolerability

    3 years

Study Arms (1)

Sequentially MRI guided and TRUS guided biopsy

EXPERIMENTAL

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

Interventions

MRI guided prostate biopsy and TRUS guided biopsyDEVICE

MRI guided prostate biopsy

Sequentially MRI guided and TRUS guided biopsy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Christian Arsov, MD

    Department of Urology, University of Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 14, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 19, 2014

Record last verified: 2012-03

Locations

DE(1)