Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

Prostate Cancer Clinical Trial

— PROMANEG  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388126
• Other study ID #: T22/2015
• Status: Completed
• Phase: N/A
• First received: March 8, 2015
• Last updated: April 16, 2018
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• 3T multiparametric 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 (1)

Lead Sponsor	Collaborator
Turku University Hospital

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 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.	3 mounths