NCT02526797

Brief Summary

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress96%
Jan 2013Dec 2026

Study Start

First participant enrolled

January 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

13.5 years

First QC Date

August 17, 2015

Last Update Submit

February 27, 2024

Conditions

Prostatic Neoplasms

Keywords

prostate biopsyprostate cancerMagnetic resonance imagingNeoplasm staging

Outcome Measures

Primary Outcomes (1)

  • Changes in the treatment planning from active surveillance to active treatment based on mp-MRI

    Observe changes in the detection-rate of significant prostate cancer using mp-MRI and mp-MRI targeted biopsies in men with newly diagnosed low risk prostate cancer enrolled i active surveillance. Mp-MRI is performed approximately 2½ month after the initial prostate biopsy.

    3 months

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with newly diagnosed low-risk prostate cancer enrolled in active surveillance at Dept. of Urology, Herlev University Hospital, from Januar 2013 to June 2015, who have had an mp-MRI of the prostate in their diagnostic follow-up.

You may qualify if:

  • Patients with low risk localized prostate cancer enrolled in active surveillance

You may not qualify if:

  • Metastatic prostate cancer
  • No mp-MRI data present
  • Prostate cancer treatment
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR \< 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Herlev University Hospital Herlev

Herlev, 2730, 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

  • Lars Boesen, MD, PhD

    Department of Urology, Herlev University Hospital Herlev, Herlev, Denmark, 2730

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 18, 2015

Study Start

January 1, 2013

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

DK(1)