Prostate CancerMULTIPROSNCT02745496
Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer
A study testing TRUS Biopsy and TRUS/FUSION Biopsy in people with Prostate Cancer, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard). Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TRUS Biopsy and TRUS/FUSION Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Dec 2020
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males between the age of 40-75 at referral
- With at least 10 years life expectancy
- With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml
- And/or abnormal Digital Rectal Examination (DRE) but < T3 disease
- Ability to informed consent
Who cannot join
- Unable to give informed consent
- Prior prostatic biopsy within 12 months
- Contraindications to biopsy
- Poor general health and life expectancy < 10 years
- Previous diagnosis of acute prostatitis within 12 months
- History of prostate cancer
Show all 9Show fewer
- Prior transurethral prostatectomy
- Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia)
- Previous hip replacement
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital and Medical School
Dundee, Tayside, DD5 4NT
About this study
Official title: Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer
The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard).
The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI.
Read more
The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies.
Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment.
Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.
Read the detailed description
There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa.
The research aims to answer the following questions:
- Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
- How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?
The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease.
Primary Objectives
- To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer
Secondary Objectives
- To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.
- Conditions
- Prostate Cancer
- Being tested
- TRUS Biopsy, TRUS/FUSION Biopsy
- Keywords
- Image-guided biopsy, Tumour detection, Diagnostic, Biomarkers
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS BiopsyProcedure or surgery
Standard of Care Treatment
TRUS/FUSION BiopsyProcedure or surgery
Interventional Treatment
| Study group | Role | What they receive |
|---|---|---|
| TRUS Biopsy | Other | Standard of Care Treatment Receives: Procedure: TRUS Biopsy |
| TRUS/FUSION Biopsy | Other | Interventional Treatment Receives: Procedure: TRUS/FUSION Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
Number of prostate cancers detected by MP-MRI when compared to gold standard
Measured: 5 years from first recruitment
Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors:
- Gleason grade >= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE)
Measured: 5 years from first recruitment
Secondary outcomes (4)
Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Number of cancer detected in each randomised group
Measured: 5 years from first recruitment
Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Number of significant cancer detected in each randomised group
Measured: 5 years from first recruitment
Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups.
Number of participants with deaths, side effects (post biopsy pain, bleeding, sepsis and hospitalization) in each of the two randomised groups.
Measured: 4 years from first recruitment
Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition.
Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology
Measured: 5 years from first recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside, Prostate Cancer UK, Tayside Clinical Trials Unit, Health Informatics Centre, Chief Scientist Office of the Scottish Government
- Responsible party
- Principal investigator, Ghulam Nabi, University of Dundee
- Investigators
- Ghulam Nabi, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745496
- Sponsor's protocol ID
- MULTIPROS Study
- Acronym
- MULTIPROS
- Status last verified
- Jun 2021
- First submitted
- 4 Mar 2016
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wei C, Szewczyk-Bieda M, Bates AS, Donnan PT, Rauchhaus P, Gandy S, Ragupathy SKA, Singh P, Coll K, Serhan J, Wilson J, Nabi G. Multicenter Randomized Trial Assessing MRI and Image-guided Biopsy for Suspected Prostate Cancer: The MULTIPROS Study. Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428.
PubMed 37489992Szewczyk-Bieda M, Wei C, Coll K, Gandy S, Donnan P, Ragupathy SKA, Singh P, Wilson J, Nabi G. A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol. Trials. 2019 Nov 21;20(1):638. doi: 10.1186/s13063-019-3746-0.
PubMed 31752954
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer
- ClinicalTrials.gov ID
- NCT02745496
- Acronym / sponsor ID
- MULTIPROS / MULTIPROS Study
- Conditions
- Prostate Cancer
- Keywords
- Image-guided biopsy, Tumour detection, Diagnostic, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside, Prostate Cancer UK, Tayside Clinical Trials Unit, Health Informatics Centre, Chief Scientist Office of the Scottish Government
- Study start
- Dec 2014 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Apr 2016 (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.
The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard).
The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI.
The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies.
Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment.
Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.
Detailed description
There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa.
The research aims to answer the following questions:
- Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
- How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?
The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease.
Primary Objectives
- To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer
Secondary Objectives
- To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUS Biopsy | Other | Procedure: TRUS BiopsyStandard of Care Treatment |
| TRUS/FUSION Biopsy | Other | Procedure: TRUS/FUSION BiopsyInterventional Treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males between the age of 40-75 at referral
- With at least 10 years life expectancy
- With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml
- And/or abnormal Digital Rectal Examination (DRE) but < T3 disease
- Ability to informed consent
Key exclusion criteria (9 listed)
- Unable to give informed consent
- Prior prostatic biopsy within 12 months
- Contraindications to biopsy
- Poor general health and life expectancy < 10 years
- Previous diagnosis of acute prostatitis within 12 months
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 |
|---|---|---|
| TRUS BiopsyStandard of Care Treatment | Procedure or surgery | TRUS Biopsy |
| TRUS/FUSION BiopsyInterventional Treatment | Procedure or surgery | TRUS/FUSION Biopsy |
Primary outcome
Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
Time frame: 5 years from first recruitment
Number of prostate cancers detected by MP-MRI when compared to gold standard
Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
Time frame: 5 years from first recruitment
The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors: o Gleason grade >= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE)
4 secondary outcomes
Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Time frame: 5 years from first recruitment
Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Time frame: 5 years from first recruitment
Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups.
Time frame: 4 years from first recruitment
Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition.
Time frame: 5 years from first recruitment
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 25 Jun 2021.
- Derived from this study: PubMed 37489992Wei C, Szewczyk-Bieda M, Bates AS, Donnan PT, Rauchhaus P, Gandy S, Ragupathy SKA, Singh P, Coll K, Serhan J, Wilson J, Nabi G. Multicenter Randomized Trial Assessing MRI and Image-guided Biopsy for Suspected Prostate Cancer: The MULTIPROS Study. Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428.
- Derived from this study: PubMed 31752954Szewczyk-Bieda M, Wei C, Coll K, Gandy S, Donnan P, Ragupathy SKA, Singh P, Wilson J, Nabi G. A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol. Trials. 2019 Nov 21;20(1):638. doi: 10.1186/s13063-019-3746-0.
- Individual participant dataSharing planned: No
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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.
Ghulam Nabi study director
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUS Biopsy and TRUS/FUSION Biopsy in people with Prostate Cancer, run by University of Dundee at 1 site in United Kingdom.
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 5 inclusion and 9 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 25 Jun 2021. 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 United Kingdom. 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?
Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen (time frame: 5 years from first recruitment). The study lists 2 primary outcomes in all. 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 NCT02745496, which also lists 2 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 25 Jun 2021.