NCT01864135

Brief Summary

Prostate cancer has been the most common cancer 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. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. This study will enroll 150 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. Multiparametric magnetic resonance imaging (mpMRI) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

April 17, 2013

Last Update Submit

January 20, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis

    Multiparametric MRI is performed in patients with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.

    3 months

Secondary Outcomes (1)

  • Predictive value of molecular markers to estimate prostate cancer diagnosis.

    3 months

Study Arms (1)

MRI

EXPERIMENTAL

Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies

Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Interventions

3T MRI (Magnetom Verio 3T, Erlangen, Germany)DEVICE
MRI
Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)DEVICE
MRI

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 40 to 85 years
  • 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

You may not qualify if:

  • previous prostate biopsy in the last 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
  • any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (4)

  • Khan MFL, Soikkeli M, Routila E, Krannila S, Terava J, Taimen P, Bostrom PJ, Pettersson K. Clinical Utility of Mutant Antibody-Based Assays for Determination of Internally Cleaved and Intact Forms of Free Prostate-Specific Antigen. J Appl Lab Med. 2019 May;3(6):1014-1021. doi: 10.1373/jalm.2018.027797. Epub 2019 Feb 1.

    PMID: 31639692DERIVED

  • Montoya Perez I, Jambor I, Pahikkala T, Airola A, Merisaari H, Saunavaara J, Alinezhad S, Vaananen RM, Tallgren T, Verho J, Kiviniemi A, Ettala O, Knaapila J, Syvanen KT, Kallajoki M, Vainio P, Aronen HJ, Pettersson K, Bostrom PJ, Taimen P. Prostate Cancer Risk Stratification in Men With a Clinical Suspicion of Prostate Cancer Using a Unique Biparametric MRI and Expression of 11 Genes in Apparently Benign Tissue: Evaluation Using Machine-Learning Techniques. J Magn Reson Imaging. 2020 May;51(5):1540-1553. doi: 10.1002/jmri.26945. Epub 2019 Oct 6.

    PMID: 31588660DERIVED

  • Jambor I, Verho J, Ettala O, Knaapila J, Taimen P, Syvanen KT, Kiviniemi A, Kahkonen E, Perez IM, Seppanen M, Rannikko A, Oksanen O, Riikonen J, Vimpeli SM, Kauko T, Merisaari H, Kallajoki M, Mirtti T, Lamminen T, Saunavaara J, Aronen HJ, Bostrom PJ. Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial. PLoS Med. 2019 Jun 3;16(6):e1002813. doi: 10.1371/journal.pmed.1002813. eCollection 2019 Jun.

    PMID: 31158230DERIVED

  • Merisaari H, Jambor I, Ettala O, Bostrom PJ, Montoya Perez I, Verho J, Kiviniemi A, Syvanen K, Kahkonen E, Eklund L, Pahikkala T, Vainio P, Saunavaara J, Aronen HJ, Taimen P. IMPROD biparametric MRI in men with a clinical suspicion of prostate cancer (IMPROD Trial): Sensitivity for prostate cancer detection in correlation with whole-mount prostatectomy sections and implications for focal therapy. J Magn Reson Imaging. 2019 Nov;50(5):1641-1650. doi: 10.1002/jmri.26727. Epub 2019 Mar 22.

    PMID: 30903647DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Hannu J Aronen, MD, PhD

    Department of Diagnostic Radiology, University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

May 29, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

November 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

FI(1)