|
Main
|
|
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:
|
12 December 2020 |
|
Main ID: |
NCT02241122 |
|
Date of registration:
|
12/09/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
MRI and Biomarkers in Prostate Cancer
Multi-IMPROD |
|
Scientific title:
|
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study) |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
350 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02241122 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Peter Boström, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Urology, University of Turku and Turku University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age: 18 to 85 years
- Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to
20 ng/ml in two following measurements and/or abnormal digital rectal examination
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved
informed consent documents in the presence of the designated staff
Exclusion Criteria:
- previous prostate biopsies within 6 months
- previous diagnosis of prostate carcinoma
- previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- symptomatic of acute prostatitis
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- uncontrolled serious infection
- claustrophobia
- hip replacement surgery or other metal implants in the pelvic area
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Prostate Cancer
|
|
Intervention(s)
|
|
Procedure: prostate biopsy
|
|
Primary Outcome(s)
|
|
Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis
[Time Frame: 18 months]
|
|
Secondary Outcome(s)
|
|
Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis
[Time Frame: 18 months]
|
|
Secondary ID(s)
|
|
72/1801/2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|