Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

NCT02388126 | Completed

• 1 other identifier: T22/2015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI

EXPERIMENTAL

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

Device: 3T multiparametric MRI; Device: Transrectal ultrasound

Interventions

3T multiparametric MRI DEVICE

Magnetom Verio 3T, Erlangen, Germany

MRI

Transrectal ultrasound DEVICE

Bk Medical Pro Focus Ultraview 2202 system

MRI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20100, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Peter J Boström, Adj. Prof.

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj. prof.

Study Record Dates

• First Submitted: March 8, 2015
• First Posted: March 13, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

FI (1)