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Prostate CancerMulti-IMPRODNCT02241122

MRI and Biomarkers in Prostate Cancer

A study testing prostate biopsy in people with Prostate Cancer, run by Turku University Hospital at 5 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
prostate biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
5 sitesFinland
Study dates
Apr 2015to 1 Apr 2018
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 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Finland5 sites

  • Department of Urology, Helsinki University Hospital

    Helsinki

  • Department of Urology, Kuopio University Hospital

    Kuopio

  • Department of Urology, Pori Central Hospital

    Pori

  • Department of Urology, Tampere University Hospital

    Tampere

  • Turku University Hospital

    Turku, 2050

Other trials in Finland

About this study

Official title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)

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.

Conditions
Prostate Cancer
Being tested
prostate biopsy
Keywords
prostate cancer, PSA, MRI, biopsy, biomarker
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prostate biopsyProcedure or surgery

Study groups in NCT02241122
Study groupRoleWhat they receive
MRI guided prostate biopsyExperimentalprostate biopsy after MR-imaging
Receives: Procedure: prostate biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

Secondary outcomes (1)

  1. 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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2017
  4. Study completion1 Apr 2018

Resources

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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241122
Sponsor's protocol ID
72/1801/2014
Acronym
Multi-IMPROD
Status last verified
Apr 2018
First submitted
12 Sep 2014
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24956412

  • 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.

    PubMed 31750988

  • 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.

    PubMed 31158230

  • 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.

    PubMed 29533507

  • 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.

    PubMed 29275146

Questions about this trial

What is this clinical trial studying?

A study testing prostate biopsy in people with Prostate Cancer, run by Turku University Hospital at 5 sites 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 biparametric MRI (T2wi+DWI) in prostate cancer diagnosis (time frame: 18 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 NCT02241122, which also lists 5 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 18 Apr 2018.

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