Clinical trial NCT02241122: MRI and Biomarkers in Prostate Cancer
Official title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
PSA
MRI
biopsy
biomarker
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2014-09-16
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis
timeFrame: 18 months
Secondary outcomes:
measure: Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis
timeFrame: 18 months
Other outcomes:
measure: Evaluation of bacterial strains
timeFrame: 18 months
Locations:
city: Helsinki
country: Finland
facility: Department of Urology, Helsinki University Hospital
city: Kuopio
country: Finland
facility: Department of Urology, Kuopio University Hospital
city: Pori
country: Finland
facility: Department of Urology, Pori Central Hospital
city: Tampere
country: Finland
facility: Department of Urology, Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Department of Urology, University of Turku and Turku University Hospital
name: Peter Boström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jambor I, Kahkonen E, Taimen P, Merisaari H, Saunavaara J, Alanen K, Obsitnik B, Minn H, Lehotska V, Aronen HJ. Prebiopsy multiparametric 3T prostate MRI in patients with elevated PSA, normal digital rectal examination, and no previous biopsy. J Magn Reson Imaging. 2015 May;41(5):1394-404. doi: 10.1002/jmri.24682. Epub 2014 Jun 23.
citation: Perez IM, Jambor I, Kauko T, Verho J, Ettala O, Falagario U, Merisaari H, Kiviniemi A, Taimen P, Syvanen KT, Knaapila J, Seppanen M, Rannikko A, Riikonen J, Kallajoki M, Mirtti T, Lamminen T, Saunavaara J, Pahikkala T, Bostrom PJ, Aronen HJ. Qualitative and Quantitative Reporting of a Unique Biparametric MRI: Towards Biparametric MRI-Based Nomograms for Prediction of Prostate Biopsy Outcome in Men With a Clinical Suspicion of Prostate Cancer (IMPROD and MULTI-IMPROD Trials). J Magn Reson Imaging. 2020 May;51(5):1556-1567. doi: 10.1002/jmri.26975. Epub 2019 Nov 21.
citation: Jambor I, Verho J, Ettala O, Knaapila J, Taimen P, Syvanen KT, Kiviniemi A, Kahkonen E, Perez IM, Seppanen M, Rannikko A, Oksanen O, Riikonen J, Vimpeli SM, Kauko T, Merisaari H, Kallajoki M, Mirtti T, Lamminen T, Saunavaara J, Aronen HJ, Bostrom PJ. Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial. PLoS Med. 2019 Jun 3;16(6):e1002813. doi: 10.1371/journal.pmed.1002813. eCollection 2019 Jun.
citation: Knaapila J, Kallio H, Hakanen AJ, Syvanen K, Ettala O, Kahkonen E, Lamminen T, Seppanen M, Jambor I, Rannikko A, Riikonen J, Munukka E, Eerola E, Gunell M, Bostrom PJ. Antibiotic susceptibility of intestinal Escherichia coli in men undergoing transrectal prostate biopsies: a prospective, registered, multicentre study. BJU Int. 2018 Aug;122(2):203-210. doi: 10.1111/bju.14198. Epub 2018 Apr 6.
citation: Knaapila J, Gunell M, Syvanen K, Ettala O, Kahkonen E, Lamminen T, Seppanen M, Jambor I, Rannikko A, Riikonen J, Munukka E, Eerola E, Hakanen AJ, Bostrom PJ. Prevalence of Complications Leading to a Health Care Contact After Transrectal Prostate Biopsies: A Prospective, Controlled, Multicenter Study Based on a Selected Study Cohort. Eur Urol Focus. 2019 May;5(3):443-448. doi: 10.1016/j.euf.2017.12.001. Epub 2017 Dec 20.