Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers

Conditions

Prostate Cancer

Brief summary

Prostate cancer has been the most common cancer 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. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries 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 clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric magnetic resonance imaging (mpMRI) at 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.

Falagario UG, Lantz A, Jambor I, Busetto GM, Bettocchi C, Finati M, Ricapito A, Luzzago S, Ferro M, Musi G, Totaro A, Racioppi M, Carbonara U, Checcucci E, Manfredi M, D'Aietti D, Porcaro AB, Nordström T, Björnebo L, Oderda M, Soria F, Taimen P, Aronen HJ, Perez IM, Ettala O, Marchioni M, Simone G, Ferriero M, Brassetti A, Napolitano L, Carmignani L, Signorini C, Conti A, Ludovico G, Scarcia M, Trombetta C, Claps F, Traunero F, Montanari E, Boeri L, Maggi M, Del Giudice F, Bove P, Forte V, Ficarra V, Rossanese M, Mucciardi G, Pagliarulo V, Tafuri A, Mirone V, Schips L, Antonelli A, Gontero P, Cormio L, Sciarra A, Porpiglia F, Bassi P, Ditonno P, Boström PJ, Messina E, Panebianco V, De Cobelli O, Carrieri G, PROMOD Study Group.

2023-10-038 citations

10.1007/s00345-023-04634-2

Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0)

Otto Ettala, Ivan Jambor, Ileana Montoya Perez, Marjo Seppänen, Antti Kaipia et al. (17 authors)

BMJ Open2022-04-017 citations

10.1136/bmjopen-2021-053118

Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study.

Falagario U, Jambor I, Taimen P, Syvänen KT, Kähkönen E, Merisaari H, Montoya Perez I, Knaapila J, Steiner A, Verho J, Tewari A, Aronen HJ, Carrieri G, Boström PJ, Ettala O.

2020-08-1013 citations

10.1007/s00345-020-03393-8

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)

Ileana Montoya Perez, Ivan Jambor, Tommi Kauko, Janne Verho, Otto Ettala et al. (21 authors)

Journal of Magnetic Resonance Imaging2019-11-2130 citations

10.1002/jmri.26975

Prostate Cancer Risk Stratification in Men With a Clinical Suspicion of Prostate Cancer Using a Unique Biparametric MRI and Expression of 11 Genes in Apparently Benign Tissue: Evaluation Using Machine‐Learning Techniques

Ileana Montoya Perez, Ivan Jambor, Tapio Pahikkala, Antti Airola, Harri Merisaari et al. (20 authors)

Journal of Magnetic Resonance Imaging2019-10-0612 citations

10.1002/jmri.26945

Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial

Ivan Jambor, Janne Verho, Otto Ettala, Juha Knaapila, Pekka Taimen et al. (22 authors)

PLoS Medicine2019-06-0358 citations

10.1371/journal.pmed.1002813

IMPROD biparametric MRI in men with a clinical suspicion of prostate cancer (IMPROD Trial): Sensitivity for prostate cancer detection in correlation with whole‐mount prostatectomy sections and implications for focal therapy

Harri Merisaari, Ivan Jambor, Otto Ettala, Peter J. Boström, Ileana Montoya Perez et al. (15 authors)

Journal of Magnetic Resonance Imaging2019-03-2220 citations

10.1002/jmri.26727

Clinical Utility of Mutant Antibody-Based Assays for Determination of Internally Cleaved and Intact Forms of Free Prostate-Specific Antigen

Md. Ferdhos L Khan, Minna Soikkeli, Erica Routila, Sandra Krannila, Joonas Terävä et al. (8 authors)

The Journal of Applied Laboratory Medicine2019-02-011 citations

10.1373/jalm.2018.027797

Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial).

Jambor I, Boström PJ, Taimen P, Syvänen K, Kähkönen E, Kallajoki M, Perez IM, Kauko T, Matomäki J, Ettala O, Merisaari H, Kiviniemi A, Dean PB, Aronen HJ.

2017-02-0664 citations

10.1002/jmri.25641

Stratification of aggressive prostate cancer from indolent disease-Prospective controlled trial utilizing expression of 11 genes in apparently benign tissue.

Alinezhad S, Väänänen RM, Tallgrén T, Perez IM, Jambor I, Aronen H, Kähkönen E, Ettala O, Syvänen K, Nees M, Kallajoki M, Taimen P, Boström PJ, Pettersson K.

2016-02-0510 citations

10.1016/j.urolonc.2015.12.014

MP17-07 RAPID PRE-PROSTATE BIOPSY MRI, RESULTS OF A CONTROLLED PROSPECTIVE REGISTERED IMPROD-TRIAL

Peter J. Boström, Pekka Taimen, Kari T. Syvänen, Esa Kähkönen, Markku Kallajoki et al. (7 authors)

The Journal of Urology2015-03-31

10.1016/j.juro.2015.02.849

Interventions

DEVICE3T MRI (Magnetom Verio 3T, Erlangen, Germany)

DEVICETransrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* Age: 40 to 85 years * Clinical suspicion of prostate cancer based on: serum level of PSA from 2,5 ng/ml to 25 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 biopsy in the last 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 * any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis	3 months	Multiparametric MRI is performed in patients with 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

Measure	Time frame	Description
Predictive value of molecular markers to estimate prostate cancer diagnosis.	3 months	molecular markers include PCR-analyses of multiple markers from biopsy material. The association of molecular marker status is used to estimate the risk of prostate cancer on biopsies.

Countries

Finland

Outcome results

None listed