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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI guided prostate biopsy | Experimental | prostate biopsy after MR-imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostate biopsy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of bacterial strains | The bacterial resistance towards antibiotics is evaluated. | 18 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Boström, MD, PhD | Department of Urology, University of Turku and Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Helsinki University Hospital | Helsinki | Finland | ||||
| Department of Urology, Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24956412 | Background | 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. | |
| 31750988 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 18 months |
| Kuopio |
| Finland |
| Department of Urology, Pori Central Hospital | Pori | Finland |
| Department of Urology, Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | 2050 | Finland |
| 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. |
| 31158230 | Derived | 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. |
| 29533507 | Derived | 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. |
| 29275146 | Derived | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |