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Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers (IMPROD2_0)

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ClinicalTrials.gov Identifier: NCT02844829
Recruitment Status : Unknown
Verified July 2016 by Hannu Aronen, Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hannu Aronen, Turku University Hospital

Brief Summary:

This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.

Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer.

Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy.

Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Prostate MRI Not Applicable

Detailed Description:

Specific aims of the current study are as follows:

i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy

ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer

iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers

iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy

v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI and biomarkers
Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.
Other: Prostate MRI
MRI of the prostate prior to prostate biobsy




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer [ Time Frame: Baseline and during procedure ]
    Serum and urine samples before prostate biopsy and tissue samples during prostatectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844829


Contacts
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Contact: Hannu J Aronen, M.D. Ph.D. +358 2 3133896 hannu.aronen@utu.fi

Locations
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Finland
Department of Urology, Turku University Hospital Recruiting
Turku, Western Finland Province, Finland, FI-20520
Contact: Peter J Boström, M.D., Ph.D    +358 2 3130243    peter.boström@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Hannu J Aronen, M.D. Ph.D. Diagnostic radiology University of Turku

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Responsible Party: Hannu Aronen, Professor, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02844829     History of Changes
Other Study ID Numbers: T166/2016
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hannu Aronen, Turku University Hospital:
Prostate Cancer
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases