NCT Number: NCT02241122
MRI and Biomarkers in Prostate Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Department of Urology, Helsinki University Hospital, Helsinki, Finland
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis
Time frame: 18 months
Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
Secondary outcomes
-
Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis
Time frame: 18 months
Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.
Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases
Other outcomes
-
Evaluation of bacterial strains
Time frame: 18 months
The bacterial resistance towards antibiotics is evaluated.
Sponsors and collaborators
Lead sponsor
Turku University Hospital
Other Gov
Registry information
Official study title
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)
Acronym: Multi-IMPROD
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Sep 16, 2014
- 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.
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