Prostatic NeoplasmsNCT01357512

Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

A study testing magnetic resonance imaging, Siemens in people with Prostatic Neoplasms, run by University of Oulu at 1 site in Finland.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 72 years, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: magnetic resonance imaging, Siemens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteFinland
Study dates: Apr 2011to Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 72 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent
Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml)
PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Who cannot join

Previous prostate biopsies
Previous prostate surgery
Contraindication for MRI (such as pacemaker or inner ear implant)
Claustrophobia
Estimated glomerular filtration rate (eGFR) <40 ml/min
Suspected clinical T3-T4 prostate cancer based on digital rectal examination
Contraindication for transrectal ultrasound-guided prostate biopsies
body mass index >30

Trial locations and contacts

1 site in 1 country.

Finland1 site

Oulu University Hospital
Oulu, 90029

Other trials in Finland

About this study

Official title: Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer

The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.

Conditions: Prostatic Neoplasms
Being tested: magnetic resonance imaging, Siemens
Keywords: prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy
Medical subject headings: Prostatic Neoplasms

What participants receive

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

magnetic resonance imaging, SiemensDevice
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

Study groups in NCT01357512
Study group	Role	What they receive
MRI done	Experimental	Subjects with MRI prior prostate biopsies Receives: Device: magnetic resonance imaging, Siemens
no MRI	No intervention	No MRI before prostate biopsies

What is being measured

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

Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.
Measured: at the end of the study (up to 1 year)

Secondary outcomes (2)

Number of Positive Biopsies in MRI and no MRI Groups
The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.
Measured: at the end of the study (up to 1 year)
Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups
Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.
Measured: at the end of the study (up to 1 year)

Timeline

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

Apr 2011Sep 2017

First posted20 May 2011 (estimated)
Study startApr 2011
Primary completionDec 2014
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01357512
Sponsor's protocol ID: PRODIAMRI
Status last verified: Oct 2017
First submitted: 14 Apr 2011
Last updated: 2 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tonttila PP, Lantto J, Paakko E, Piippo U, Kauppila S, Lammentausta E, Ohtonen P, Vaarala MH. Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial. Eur Urol. 2016 Mar;69(3):419-25. doi: 10.1016/j.eururo.2015.05.024. Epub 2015 May 29.
PubMed 26033153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer
ClinicalTrials.gov ID: NCT01357512
Acronym / sponsor ID: PRODIAMRI
Conditions: Prostatic Neoplasms
Keywords: prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: University of OuluUniversity, hospital or other
Collaborators: Oulu University Hospital
Study start: Apr 2011
Primary completion: Dec 2014 (actual)
Study completion: Sep 2017 (actual)
First posted: 20 May 2011 (estimated)
Results: Posted 17 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRI done	Experimental	Device: magnetic resonance imaging, SiemensSubjects with MRI prior prostate biopsies
no MRI	No intervention	–No MRI before prostate biopsies

Who may qualify

Ages: 40 to 72 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Informed consent
Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml)
PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Key exclusion criteria (8 listed)

Previous prostate biopsies
Previous prostate surgery
Contraindication for MRI (such as pacemaker or inner ear implant)
Claustrophobia
Estimated glomerular filtration rate (eGFR) <40 ml/min

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
magnetic resonance imaging, SiemensMagnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device	Device	MRI done

Primary outcome

Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
Time frame: at the end of the study (up to 1 year)
The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

2 secondary outcomes

Number of Positive Biopsies in MRI and no MRI Groups
Time frame: at the end of the study (up to 1 year)
Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups
Time frame: at the end of the study (up to 1 year)

Results and safety

Results posted to the registry on 17 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI Done	65	53
no MRI	65	60

Primary outcome: Number of Prostate Cancer Diagnoses in MRI and no MRI Groups

Time frame: at the end of the study (up to 1 year). Number. Unit: participants

Measure	MRI Done n = 53	no MRI n = 60
Value	34	34

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Done	0 of 53 (0%)	0 of 53 (0%)	Not reported
no MRI	0 of 60 (0%)	1 of 60 (1.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26033153Tonttila PP, Lantto J, Paakko E, Piippo U, Kauppila S, Lammentausta E, Ohtonen P, Vaarala MH. Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial. Eur Urol. 2016 Mar;69(3):419-25. doi: 10.1016/j.eururo.2015.05.024. Epub 2015 May 29.

Related trials for Prostatic Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

Markku Vaarala, MD PhD principal investigator

Oulu University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing magnetic resonance imaging, Siemens in people with Prostatic Neoplasms, run by University of Oulu 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 2 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Prostate Cancer Diagnoses in MRI and no MRI Groups (time frame: at the end of the study (up to 1 year)). 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 NCT01357512, which also lists 1 linked publication.

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 2 Dec 2017.