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

NCT ID: NCT02844829

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI and biomarkers

Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.

Group Type: OTHER

Prostate MRI

Intervention Type: OTHER

MRI of the prostate prior to prostate biobsy

Interventions

Prostate MRI

MRI of the prostate prior to prostate biobsy

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hannu Aronen

Professor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannu J Aronen, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Diagnostic radiology University of Turku

Locations

Department of Urology, Turku University Hospital

Turku, Western Finland Province, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Hannu J Aronen, M.D. Ph.D.

Role: CONTACT

hannu.aronen@utu.fi

+358 2 3133896

Facility Contacts

Peter J Boström, M.D., Ph.D

Role: primary

peter.boström@tyks.fi

+358 2 3130243

Other Identifiers

T166/2016

Identifier Type: -

Identifier Source: org_study_id