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MRI and Biomarkers in Prostate Cancer (Multi-IMPROD)

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ClinicalTrials.gov Identifier: NCT02241122
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:

Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 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 Procedure: prostate biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)
Study Start Date : April 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI guided prostate biopsy
prostate biopsy after MR-imaging
Procedure: prostate biopsy



Primary Outcome Measures :
  1. Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis [ Time Frame: 18 months ]
    Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.


Secondary Outcome Measures :
  1. Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis [ Time Frame: 18 months ]

    Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.

    Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases



Other Outcome Measures:
  1. Evaluation of bacterial strains [ Time Frame: 18 months ]
    The bacterial resistance towards antibiotics is evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT02241122


Locations
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Finland
Department of Urology, Helsinki University Hospital
Helsinki, Finland
Department of Urology, Kuopio University Hospital
Kuopio, Finland
Department of Urology, Pori Central Hospital
Pori, Finland
Department of Urology, Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland, 2050
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Peter Boström, MD, PhD Department of Urology, University of Turku and Turku University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02241122     History of Changes
Other Study ID Numbers: 72/1801/2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Turku University Hospital:
prostate cancer
PSA
MRI
biopsy
biomarker

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