Prostate CancerIMPRODNCT01864135
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers
A study testing 3T MRI (Magnetom Verio 3T, Erlangen, Germany) and Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system) in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3T MRI (Magnetom Verio 3T, Erlangen, Germany) and Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
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.
- Conditions
- Prostate Cancer
- Being tested
- 3T MRI (Magnetom Verio 3T, Erlangen, Germany), Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRI (Magnetom Verio 3T, Erlangen, Germany)Device
Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany); Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
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.
Measured: 3 months
Secondary outcomes (1)
Predictive value of molecular markers to estimate prostate cancer diagnosis.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Hannu J Aronen, MD, PhD, Principal investigator, Department of Diagnostic Radiology, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864135
- Sponsor's protocol ID
- 112/180/2012
- Acronym
- IMPROD
- Status last verified
- Jan 2016
- First submitted
- 17 Apr 2013
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Khan MFL, Soikkeli M, Routila E, Krannila S, Terava J, Taimen P, Bostrom PJ, Pettersson K. Clinical Utility of Mutant Antibody-Based Assays for Determination of Internally Cleaved and Intact Forms of Free Prostate-Specific Antigen. J Appl Lab Med. 2019 May;3(6):1014-1021. doi: 10.1373/jalm.2018.027797. Epub 2019 Feb 1.
PubMed 31639692Montoya Perez I, Jambor I, Pahikkala T, Airola A, Merisaari H, Saunavaara J, Alinezhad S, Vaananen RM, Tallgren T, Verho J, Kiviniemi A, Ettala O, Knaapila J, Syvanen KT, Kallajoki M, Vainio P, Aronen HJ, Pettersson K, Bostrom PJ, Taimen P. 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. J Magn Reson Imaging. 2020 May;51(5):1540-1553. doi: 10.1002/jmri.26945. Epub 2019 Oct 6.
PubMed 31588660Jambor 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.
PubMed 31158230Merisaari H, Jambor I, Ettala O, Bostrom PJ, Montoya Perez I, Verho J, Kiviniemi A, Syvanen K, Kahkonen E, Eklund L, Pahikkala T, Vainio P, Saunavaara J, Aronen HJ, Taimen P. 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. J Magn Reson Imaging. 2019 Nov;50(5):1641-1650. doi: 10.1002/jmri.26727. Epub 2019 Mar 22.
PubMed 30903647
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01864135
- Acronym / sponsor ID
- IMPROD / 112/180/2012
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany), Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T MRI (Magnetom Verio 3T, Erlangen, Germany) | Device | MRI |
| Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system) | Device | MRI |
Primary outcome
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
Time frame: 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.
1 secondary outcome
Predictive value of molecular markers to estimate prostate cancer diagnosis.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 31639692Khan MFL, Soikkeli M, Routila E, Krannila S, Terava J, Taimen P, Bostrom PJ, Pettersson K. Clinical Utility of Mutant Antibody-Based Assays for Determination of Internally Cleaved and Intact Forms of Free Prostate-Specific Antigen. J Appl Lab Med. 2019 May;3(6):1014-1021. doi: 10.1373/jalm.2018.027797. Epub 2019 Feb 1.
- Derived from this study: PubMed 31588660Montoya Perez I, Jambor I, Pahikkala T, Airola A, Merisaari H, Saunavaara J, Alinezhad S, Vaananen RM, Tallgren T, Verho J, Kiviniemi A, Ettala O, Knaapila J, Syvanen KT, Kallajoki M, Vainio P, Aronen HJ, Pettersson K, Bostrom PJ, Taimen P. 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. J Magn Reson Imaging. 2020 May;51(5):1540-1553. doi: 10.1002/jmri.26945. Epub 2019 Oct 6.
- Derived from this study: PubMed 31158230Jambor 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.
- Derived from this study: PubMed 30903647Merisaari H, Jambor I, Ettala O, Bostrom PJ, Montoya Perez I, Verho J, Kiviniemi A, Syvanen K, Kahkonen E, Eklund L, Pahikkala T, Vainio P, Saunavaara J, Aronen HJ, Taimen P. 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. J Magn Reson Imaging. 2019 Nov;50(5):1641-1650. doi: 10.1002/jmri.26727. Epub 2019 Mar 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu J Aronen, MD, PhD principal investigator
Department of Diagnostic Radiology, University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3T MRI (Magnetom Verio 3T, Erlangen, Germany) and Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system) in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864135, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.