NCT02326246

Brief Summary

The purpose of this study is to investigate the hypothesis, that mMRI provides a more accurate and secure interpretation of the aggressiveness of prostate cancer initially/before mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on gleason score upgrade, risk classification upgrade and changes in treatment strategy (active surveillance vs. operation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

December 22, 2014

Last Update Submit

March 20, 2017

Conditions

Prostate Cancer

Keywords

MRIactive surveillance

Outcome Measures

Primary Outcomes (1)

  • gleason up-grate

    1 year

Secondary Outcomes (1)

  • changes in the treatment strategy

    1 year

Study Arms (1)

men with low-risk PC

EXPERIMENTAL

men newly diagnosed with low-risk prostate cancer and put in an active surveillance (AS) program. Eight weeks post TRUS-guided biopsies they are scanned with a multi-parametric magnetic resonans imaging (mMRI). If the scans shows a PIRADS 4 or 5 lesion, MRI-guided biopsies are performed. Otherwise the patients will continue in the AS program as usual. The mMRI will in these cases be repeated after 1 year.

Other: multi-parametic MRI

Interventions

multi-parametic MRIOTHER
men with low-risk PC

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years
  • PC and put in AC,
  • No contraindications to MRI,
  • Written informed consent

You may not qualify if:

  • Lack of ability to consent,
  • Non-MRI compatible metal in the body,
  • Claustrophobia,
  • Heavy obesity (largest circumference more than 180 cm),
  • Moderate/severe kidney malfunction
  • Known allergy to MRI contrast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Maria C Elkjær, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ph.d. student

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 29, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

DK(1)