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

NCT02844829 | Unknown

• 1 other identifier: T166/2016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (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

  Baseline (MRI prior to prostate biopsy)

Secondary Outcomes (1)

• Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer

  Baseline and during procedure

Study Arms (1)

MRI and biomarkers

OTHER

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

Other: Prostate MRI

Interventions

Prostate MRI OTHER

MRI of the prostate prior to prostate biobsy

MRI and biomarkers

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Department of Urology, Turku University Hospital

Turku, Western Finland Province, FI-20520, Finland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hannu J Aronen, M.D. Ph.D.

  Diagnostic radiology University of Turku

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+358 2 3133896; hannu.aronen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

FI (1)