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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 March 2024
Main ID:  NCT02526797
Date of registration: 17/08/2015
Prospective Registration: No
Primary sponsor: Herlev Hospital
Public title: Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance
Scientific title: Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance
Date of first enrolment: January 2013
Target sample size: 150
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/ct2/show/NCT02526797
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Denmark
Contacts
Name:     Lars Boesen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Urology, Herlev University Hospital Herlev, Herlev, Denmark, 2730
Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Prostatic Neoplasms
Intervention(s)
Primary Outcome(s)
Changes in the treatment planning from active surveillance to active treatment based on mp-MRI [Time Frame: 3 months]
Secondary Outcome(s)
Secondary ID(s)
HEH-2015-058
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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