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

Prostate Cancer Clinical Trial

— IMPROD  

Official title:

Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864135
• Other study ID #: 112/180/2012
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: January 20, 2016
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 3T MRI (Magnetom Verio 3T, Erlangen, Germany)

• Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Predictive value of molecular markers to estimate prostate cancer diagnosis.	molecular markers include PCR-analyses of multiple markers from biopsy material. The association of molecular marker status is used to estimate the risk of prostate cancer on biopsies.	3 months	No