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

Prostate Cancer Clinical Trial

— IMPROD2_0  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844829
• Other study ID #: T166/2016
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 25, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Turku University Hospital
• Contact: Hannu J Aronen, M.D. Ph.D.
• Phone: +358 2 3133896
• Email: hannu.aronen[@]utu.fi
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Prostate MRI
MRI of the prostate prior to prostate biobsy

Locations

Country	Name	City	State
Finland	Department of Urology, Turku University Hospital	Turku	Western Finland Province

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer	Serum and urine samples before prostate biopsy and tissue samples during prostatectomy	Baseline and during procedure	No