MRI and Biomarkers in Prostate Cancer (Multi-IMPROD)

Turku University Hospital (TYKS)

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02241122

72/1801/2014

Details and patient eligibility

About

Prostate cancer has been the most common neoplastic disease 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. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This prospective multi-institutional study will enroll 400 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. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 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.

Enrollment: 350 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 to 85 years
• Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 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 within 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
• hip replacement surgery or other metal implants in the pelvic area

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

MRI guided prostate biopsy

Experimental group

Description:

prostate biopsy after MR-imaging

Treatment:

Procedure: prostate biopsy