Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, 20100, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3T multiparametric MRI

Device

Magnetom Verio 3T, Erlangen, Germany

Transrectal Ultrasound

Device

Bk Medical Pro Focus Ultraview 2202 system

Primary outcomes

Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis

Time frame: 3 mounths

Multiparametric MRI is performed in patients with previous negative biopsies with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE) or in patients in active surveillance due to low risk prostate carcinoma. The accuracy will be determined using the results from transrectal ultrasound guided biopsies.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Acronym: PROMANEG

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 13, 2015
Registry last updated: Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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