Prostate CancerPRECISENCT02936258
PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures
A study testing MRI and MRI Targeted Biopsy in people with Prostate Cancer, run by Canadian Urology Research Consortium at 5 sites in Canada.
Trial summary
The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI and MRI Targeted Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesCanada
- Study dates
- Nov 2016to Nov 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible, all inclusion criteria must be met:
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy;
- ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
- Serum PSA ≤ 20ng/ml within 3 months of randomization
- 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 GFR ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI, i.e. 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
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
London Health Sciences Centre-Victoria Hospital
London, Ontario, N6A5W9
Stephanie Horst, 519-685-8500 ext. 56601, stephanie.horst@lhsc.on.ca
Joseph Chin, MD
- Recruiting
CIUSSS du Centre-Ouest-de-I'ile-de-Montreal-Jewish General Hospital
Montreal, Quebec, H3T1E2
Oleg Loutochin, 514-340-8222 ext. 21627, oloutochin@jgh.mcgill.ca
Franck Bladou, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Marlene Kebabdjian, 416-480-6100 ext. 2890, marlene.kebabdjian@sunnybrook.ca
Laurence Klotz, MD
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G1X6
Michael Nesbitt, 416-946-4501 ext. 6897, michael.nesbitt@uhn.ca
Antonio Finelli, MD
- Not yet recruiting
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z1M9
Antonio Hurtado-Coll, ahurtado@prostatecentre.com
Peter Black, MD
About this study
Official title: A Phase III Multi-centre Open-label Randomized Controlled Trial of Multi-parametric Magnetic Resonance Imaging (MRI)-Targeted Biopsy Compared to Systematic Trans-rectal Ultrasound (TRUS) Guided Biopsy
The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.
Read the detailed description
The standard pathway for prostate cancer diagnosis is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following an elevated PSA. TRUS guidance is performed primarily for anatomic guidance as the ultrasound poorly discriminates between cancerous and non-cancerous tissue. TRUS guided prostate biopsies are concentrated in areas of the peripheral zone, thought to harbor the majority of cancer.
An alternative pathway for prostate cancer diagnosis in men with elevated PSA is to perform multi-parametric magnetic resonance imaging (MPMRI) to localize cancer. This information is used to direct a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar or greater amount of clinically significant cancer than systematic TRUS guided biopsy and has several other potential advantages including: the ability to differentiate between clinically significant and insignificant cancer, reducing unnecessary biopsy and fewer numbers of biopsy cores, reducing biopsy-related side-effects.
A 'clinically insignificant cancer' is cancer that is unlikely to progress or to affect an individual's life expectancy and therefore does not warrant treatment. However when diagnosed with low grade cancer that is likely to be insignificant, a large proportion of subjects request treatment in case a more significant cancer is present. A challenge in this area is that subjects are typically not aware that their cancer is clinically insignificant, and often view the early diagnosis and aggressive treatment they have been subjected to as life-saving.
A prostate cancer detection procedure that differentiates clinically significant cancer from clinically insignificant cancer is therefore a major unmet need.
The potential implications of this trial include:
- A redefinition of the prostate cancer diagnostic pathway;
- A reduction in the number of subjects undergoing prostate biopsy;
- A reduction in the number of biopsy cores taken per subject;
- A reduction in biopsy-related adverse events including sepsis and pain;
- A reduction in the over-diagnosis of clinically insignificant prostate cancer;
- A reduction in the economic burden of diagnosing and treating prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Standard of Care, MRI, MRI Targeted 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.
Standard of CareProcedure or surgery
Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
MRIProcedure or surgery
Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
MRI Targeted BiopsyProcedure or surgery
Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years. Receives: Procedure: MRI; Procedure: MRI Targeted Biopsy |
| Standard of Care | Active comparator | Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first). Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-The proportion of men with clinically significant cancer (Gleason > 7)
To determine whether the proportion of men with clinically significant cancer (Gleason > 7) detected by MRI-targeted biopsy is no less than systematic TRUS guided biopsy.
Measured: 1 year
Secondary outcomes (6)
Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7)
- The proportion of men with clinically significant cancer (Gleason ≥7) detected by MRI-targeted biopsy is greater than systematic TRUS guided biopsy.
Measured: 1 year
Proportion of men in each arm with clinically insignificant cancer
Measured: 1 year
Proportion of men in each arm with Gleason >4+3 detected.
Measured: 1 year
Proportion of men in MRI arm who avoid biopsy.
Measured: 1 year
Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected.
Measured: 1 year
Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Urology Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Prostate Cancer Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936258
- Sponsor's protocol ID
- PRECISE Trial
- Acronym
- PRECISE
- Status last verified
- Jan 2018
- First submitted
- 28 Sep 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Plan to share publication
Publications
Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Machado A, Levental M, Ghai S, Chang SD, Patel C, Kassam Z, Loblaw A, Kebabdjian M, Pond G, Haider MA. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of a Prospective Randomized Trial (PRECISE). Eur Urol Oncol. 2024 Jun;7(3):456-461. doi: 10.1016/j.euo.2023.09.013. Epub 2023 Oct 12.
PubMed 37838556Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Bladou F, Mercado A, Levental M, Ghai S, Chang SD, Milot L, Patel C, Kassam Z, Moore C, Kasivisvanathan V, Loblaw A, Kebabdjian M, Earle CC, Pond GR, Haider MA. Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):534-542. doi: 10.1001/jamaoncol.2020.7589.
PubMed 33538782
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-centre Open-label Randomized Controlled Trial of Multi-parametric Magnetic Resonance Imaging (MRI)-Targeted Biopsy Compared to Systematic Trans-rectal Ultrasound (TRUS) Guided Biopsy
- ClinicalTrials.gov ID
- NCT02936258
- Acronym / sponsor ID
- PRECISE / PRECISE Trial
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Canadian Urology Research ConsortiumUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Prostate Cancer Canada
- Study start
- Nov 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Oct 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 aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.
Detailed description
The standard pathway for prostate cancer diagnosis is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following an elevated PSA. TRUS guidance is performed primarily for anatomic guidance as the ultrasound poorly discriminates between cancerous and non-cancerous tissue. TRUS guided prostate biopsies are concentrated in areas of the peripheral zone, thought to harbor the majority of cancer.
An alternative pathway for prostate cancer diagnosis in men with elevated PSA is to perform multi-parametric magnetic resonance imaging (MPMRI) to localize cancer. This information is used to direct a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar or greater amount of clinically significant cancer than systematic TRUS guided biopsy and has several other potential advantages including: the ability to differentiate between clinically significant and insignificant cancer, reducing unnecessary biopsy and fewer numbers of biopsy cores, reducing biopsy-related side-effects.
A 'clinically insignificant cancer' is cancer that is unlikely to progress or to affect an individual's life expectancy and therefore does not warrant treatment. However when diagnosed with low grade cancer that is likely to be insignificant, a large proportion of subjects request treatment in case a more significant cancer is present. A challenge in this area is that subjects are typically not aware that their cancer is clinically insignificant, and often view the early diagnosis and aggressive treatment they have been subjected to as life-saving.
A prostate cancer detection procedure that differentiates clinically significant cancer from clinically insignificant cancer is therefore a major unmet need.
The potential implications of this trial include:
- A redefinition of the prostate cancer diagnostic pathway;
- A reduction in the number of subjects undergoing prostate biopsy;
- A reduction in the number of biopsy cores taken per subject;
- A reduction in biopsy-related adverse events including sepsis and pain;
- A reduction in the over-diagnosis of clinically insignificant prostate cancer;
- A reduction in the economic burden of diagnosing and treating prostate cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Procedure: MRI, Procedure: MRI Targeted BiopsyMen in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years. |
| Standard of Care | Active comparator | Procedure: Standard of CareMen in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy;
- ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
- Serum PSA ≤ 20ng/ml within 3 months of randomization
- Fit to undergo all procedures listed in protocol;
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
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 |
|---|---|---|
| Standard of CareMen in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first). | Procedure or surgery | Standard of Care |
| MRIMen will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. | Procedure or surgery | MRI |
| MRI Targeted BiopsyMen will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. | Procedure or surgery | MRI |
Primary outcome
MRI-The proportion of men with clinically significant cancer (Gleason > 7)
Time frame: 1 year
To determine whether the proportion of men with clinically significant cancer (Gleason > 7) detected by MRI-targeted biopsy is no less than systematic TRUS guided biopsy.
6 secondary outcomes
Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7)
Time frame: 1 year
Proportion of men in each arm with clinically insignificant cancer
Time frame: 1 year
Proportion of men in each arm with Gleason >4+3 detected.
Time frame: 1 year
Proportion of men in MRI arm who avoid biopsy.
Time frame: 1 year
Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected.
Time frame: 1 year
Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 37838556Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Machado A, Levental M, Ghai S, Chang SD, Patel C, Kassam Z, Loblaw A, Kebabdjian M, Pond G, Haider MA. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of a Prospective Randomized Trial (PRECISE). Eur Urol Oncol. 2024 Jun;7(3):456-461. doi: 10.1016/j.euo.2023.09.013. Epub 2023 Oct 12.
- Derived from this study: PubMed 33538782Klotz L, Chin J, Black PC, Finelli A, Anidjar M, Bladou F, Mercado A, Levental M, Ghai S, Chang SD, Milot L, Patel C, Kassam Z, Moore C, Kasivisvanathan V, Loblaw A, Kebabdjian M, Earle CC, Pond GR, Haider MA. Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):534-542. doi: 10.1001/jamaoncol.2020.7589.
- Individual participant dataSharing planned: Yes. Plan to share publication
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and MRI Targeted Biopsy in people with Prostate Cancer, run by Canadian Urology Research Consortium at 5 sites in Canada.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Dr Klotz, MD (416-480-4673, laurence.klotz@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-The proportion of men with clinically significant cancer (Gleason > 7) (time frame: 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 NCT02936258, 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 22 Feb 2018.