Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies (PROMANEG)

Turku University Hospital (TYKS)

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Transrectal ultrasound; Device: 3T multiparametric MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02388126

T22/2015

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. While, as many as 47% of the ultra-sound guided biopsies may be false negative and biopsies carry 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 previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal examination (DRE) or patients in active surveillance due to low risk prostate carcinoma. 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. In addition to routine 12-core TRUS biopsies, targeted TRUS guided biopsy based on MRI findings will be performed.

Enrollment: 150 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Language spoken: Finnish or Swedish
• Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
• Previous diagnosis of prostate carcinoma and patient on active surveillance
• 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

• Language spoken: Finnish or Swedish
• Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
• Previous diagnosis of prostate carcinoma and patient on active surveillance
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

MRI

Experimental group

Description:

Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies

Treatment:

Device: 3T multiparametric MRI

Device: Transrectal ultrasound