Prostate NeoplasmPhase 3PRECISIONNCT02380027
PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not?
A Phase 3 study testing MRI, MRI-targeted biopsy and TRUS-biopsy in people with Prostate Neoplasm, run by University College, London at 1 site in United Kingdom.
Trial summary
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm
- What is being tested?
- MRI, MRI-targeted biopsy and TRUS-biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 31 Dec 2017
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml within the previous 3 months
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Who cannot join
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
- Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
- Unfit to undergo any procedures listed in protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.
We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.
Read the detailed description
The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for prostate cancer diagnosis in the majority of centres. It has many advantages and can be performed routinely under local anaesthetic in an outpatient setting. However it does have some limitations, including the over-diagnosis of insignificant cancer and the under-diagnosis of significant cancer.
An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.
The potential implications of this trial include:
- A redefining of the prostate cancer diagnostic pathway
- A reduction in the number of patients undergoing prostate biopsy
- A reduction in the number of biopsy cores taken per patient
- A reduction in biopsy-related sepsis, pain and other side effects
- A reduction in the over-diagnosis of clinically insignificant prostate cancer
- A reduction of the economic burden of diagnosing and treating prostate cancer
- Conditions
- Prostate Neoplasm
- Being tested
- MRI, MRI-targeted biopsy, TRUS-biopsy
- Keywords
- Prostate biopsy, MRI, transrectal, Detection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
This will be a multi-parametric MRI of the prostate
MRI-targeted biopsyProcedure or surgery
This will be a biopsy targeted to suspicious areas on the MRI
TRUS-biopsyProcedure or surgery
This will be a standard 12 core trans-rectal prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| MRI-arm | Experimental | Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken. Receives: Device: MRI; Procedure: MRI-targeted biopsy |
| TRUS-biopsy arm | Active comparator | Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy Receives: Procedure: TRUS-biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men with clinically significant detected
Measured: When histology results available, at an expected average of 30 days post-biopsy
Secondary outcomes (9)
Proportion of men in MRI arm who avoid biopsy
Measured: When MRI results available, at an expected average of 30 days post-MRI
Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected
Measured: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men who go on to definitive treatment for prostate cancer
Definitive treatment can be localised (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic (hormone therapy, chemotherapy)
Measured: After treatment decision, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Cancer core length in mm
Measured: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with post-biopsy adverse events
Measured: 30 days post biopsy
EQ-5D-5L Quality of Life scores
EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state.
Measured: Baseline, 24 hours post intervention and 30 days post intervention
Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading
Measured: An expected average of 90 days post-biopsy
Cost per diagnosis of cancer
Measured: 30 days post-biopy
Proportion of men with clinically insignificant detected
Measured: When histology results available, at an expected average of 30 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 NeoplasmStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospital, Lille, Radboud University Medical Center, London North West Healthcare NHS Trust, Royal Free Hospital NHS Foundation Trust, Sunnybrook Health Sciences Centre, University College London Hospitals, University Ghent, Helsinki University Central Hospital, Jewish General Hospital, University of Roma La Sapienza, Göteborg University, Erasmus Medical Center, Hunter Holmes Mcguire Veteran Affairs Medical Center, University Hospital Heidelberg, University Hospital, Aachen, Hampshire Hospitals NHS Foundation Trust, Princess Alexandra Hospital NHS Trust, San Raffaele University Hospital, Italy, M.D. Anderson Cancer Center, University Hospital Southampton NHS Foundation Trust, University of Oulu, The Whittington Hospital NHS Trust, University Hospital of Cologne, Mayo Clinic, Centro de Urologia Argentina, Weill Medical College of Cornell University, University of Chicago, University Hospital, Bordeaux
- Responsible party
- Principal investigator, Veeru Kasivisvanathan, University College, London
- Investigators
- Caroline Moore, MD FRCS, Study chair, University College Hospital London and University College LondonMark Emberton, MD FRCS, Study chair, University College Hospital London and University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380027
- Sponsor's protocol ID
- DRF-2014-07-146
- Acronym
- PRECISION
- Status last verified
- Apr 2018
- First submitted
- 23 Feb 2015
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
PubMed 29552975Kasivisvanathan V, Jichi F, Klotz L, Villers A, Taneja SS, Punwani S, Freeman A, Emberton M, Moore CM. A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol. BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863.
PubMed 29025845
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
- ClinicalTrials.gov ID
- NCT02380027
- Acronym / sponsor ID
- PRECISION / DRF-2014-07-146
- Conditions
- Prostate Neoplasm
- Keywords
- Prostate biopsy, MRI, transrectal, Detection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospital, Lille, Radboud University Medical Center, London North West Healthcare NHS Trust, Royal Free Hospital NHS Foundation Trust, Sunnybrook Health Sciences Centre, University College London Hospitals, University Ghent, Helsinki University Central Hospital, Jewish General Hospital, University of Roma La Sapienza, Göteborg University, Erasmus Medical Center, Hunter Holmes Mcguire Veteran Affairs Medical Center, University Hospital Heidelberg, University Hospital, Aachen, Hampshire Hospitals NHS Foundation Trust, Princess Alexandra Hospital NHS Trust, San Raffaele University Hospital, Italy, M.D. Anderson Cancer Center, University Hospital Southampton NHS Foundation Trust, University of Oulu, The Whittington Hospital NHS Trust, University Hospital of Cologne, Mayo Clinic, Centro de Urologia Argentina, Weill Medical College of Cornell University, University of Chicago, University Hospital, Bordeaux
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Mar 2015 (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.
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.
We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.
Detailed description
The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for prostate cancer diagnosis in the majority of centres. It has many advantages and can be performed routinely under local anaesthetic in an outpatient setting. However it does have some limitations, including the over-diagnosis of insignificant cancer and the under-diagnosis of significant cancer.
An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.
The potential implications of this trial include:
- A redefining of the prostate cancer diagnostic pathway
- A reduction in the number of patients undergoing prostate biopsy
- A reduction in the number of biopsy cores taken per patient
- A reduction in biopsy-related sepsis, pain and other side effects
- A reduction in the over-diagnosis of clinically insignificant prostate cancer
- A reduction of the economic burden of diagnosing and treating prostate cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI-arm | Experimental | Device: MRI, Procedure: MRI-targeted biopsyMen in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken. |
| TRUS-biopsy arm | Active comparator | Procedure: TRUS-biopsyMen in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml within the previous 3 months
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
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 |
|---|---|---|
| MRIThis will be a multi-parametric MRI of the prostate | Device | MRI-arm |
| MRI-targeted biopsyThis will be a biopsy targeted to suspicious areas on the MRI | Procedure or surgery | MRI-arm |
| TRUS-biopsyThis will be a standard 12 core trans-rectal prostate biopsy | Procedure or surgery | TRUS-biopsy arm |
Primary outcome
Proportion of men with clinically significant detected
Time frame: When histology results available, at an expected average of 30 days post-biopsy
9 secondary outcomes
Proportion of men in MRI arm who avoid biopsy
Time frame: When MRI results available, at an expected average of 30 days post-MRI
Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men who go on to definitive treatment for prostate cancer
Time frame: After treatment decision, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with post-biopsy adverse events
Time frame: 30 days post biopsy
EQ-5D-5L Quality of Life scores
Time frame: Baseline, 24 hours post intervention and 30 days post intervention
Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading
Time frame: An expected average of 90 days post-biopsy
Cost per diagnosis of cancer
Time frame: 30 days post-biopy
Proportion of men with clinically insignificant detected
Time frame: When histology results available, at an expected average of 30 days post-biopsy
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 1 May 2018.
- Derived from this study: PubMed 29552975Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
- Derived from this study: PubMed 29025845Kasivisvanathan V, Jichi F, Klotz L, Villers A, Taneja SS, Punwani S, Freeman A, Emberton M, Moore CM. A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol. BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863.
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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.
Caroline Moore, MD FRCS study chair
University College Hospital London and University College London
Mark Emberton, MD FRCS study chair
University College Hospital London and University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRI, MRI-targeted biopsy and TRUS-biopsy in people with Prostate Neoplasm, run by University College, London 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 7 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 1 May 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of men with clinically significant detected (time frame: When histology results available, at an expected average of 30 days post-biopsy). 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 NCT02380027, 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 1 May 2018.