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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02844829 |
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Date of registration:
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22/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
IMPROD2_0 |
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Scientific title:
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Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02844829 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Hannu J Aronen, M.D. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Diagnostic radiology University of Turku |
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Name:
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Peter J Boström, M.D., Ph.D |
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Address:
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Telephone:
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+358 2 3130243 |
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Email:
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peter.boström@tyks.fi |
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Affiliation:
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Name:
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Hannu J Aronen, M.D. Ph.D. |
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Address:
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Telephone:
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+358 2 3133896 |
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Email:
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hannu.aronen@utu.fi |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 40 to 85 years
- Language spoken: Finnish
- Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to
25 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
- 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
- any other conditions that might compromise patients safety, based on the clinical
judgment of the responsible urologist
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Other: Prostate MRI
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Primary Outcome(s)
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Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
[Time Frame: Baseline (MRI prior to prostate biopsy)]
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Secondary Outcome(s)
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Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
[Time Frame: Baseline and during procedure]
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Secondary ID(s)
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T166/2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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