Prostate CancerNCT02488096
Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy
A study testing TRUS-Guided Biopsy and MRI + TRUS-Guided Biopsy in people with Prostate Cancer, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
Trial summary
The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies. 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?
- TRUS-Guided Biopsy and MRI + TRUS-Guided Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Jan 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
- Referred for an ultrasound-guided prostate biopsy
- Indication 1: Men without a history of prostate cancer referred to the PAC for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy
- Indication 2: Men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the PAC for a follow-up biopsy
Who cannot join
- Are unable to consent on their own behalf
- Less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding MRI image)
- A history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy)
- Emergent/urgent biopsy referrals
- History of urinary tract infections or prostatitis in the last 3 months
- Contraindications to MRI:
Show all 10Show fewer
- Ferromagnetic or otherwise non-MRI compatible aneurysm clips
- The presence of an implanted pacemaker or implanted defibrillator device
- Contraindication to receiving Gadolinium containing contrast for the which may include past or current kidney disease or injury or kidney transplant
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.
Read the detailed description
Accurately diagnosing clinically significant prostate cancer at a time when the benefits of treatment outweigh the harm continues to elude clinicians because of the complex nature of prostate cancer. When patients are found to have a high prostate specific antigen (PSA) blood test, an abnormal digital rectal exam, or they have prostate cancer but are delaying treatment (active surveillance), they are referred for transrectal ultrasound (TRUS) guided biopsy. The sensitivity of TRUS with 12-core biopsies is only 53-68% so cancers can be missed, particularly in the anterior region of the prostate. In some cases, TRUS can be used to rule out other causes of abnormal test findings, however the specificity of TRUS is also fairly poor making it difficult for a man to know for certain if he is cancer free. Unfortunately, biopsies also cause serious side effects including incontinence, bowel dysfunction, infection and pain. Increasing the number of cores taken during biopsy does not typically translate to better detection rates.
Magnetic resonance imaging (MRI) has much greater resolution than TRUS and can therefore, detect changes in the prostate more accurately. If conducted prior to a targeted biopsy, MRI can also reduce the number of cores taken compared to a standard biopsy (e.g. 2-4 cores vs. 12 cores), which could reduce biopsy side effects while simultaneously increasing detection of clinically significant cancer compared to routine 12-core biopsies and saving health care system dollars. Technology that combines MRI at the same time as biopsy (MRI-TRUS fusion biopsy) is increasingly being used, with some promising results. However, these techniques require expensive equipment and specially-trained personnel, and are more time-consuming and restrictive in when the procedure can occur. Utilizing MRI prior to a TRUS-guided biopsy could provide the same benefits in terms of cancer detection, but at a more reasonable cost and shorter wait-times as MRI alone can be done in a variety of settings and times.
If the results of this study demonstrate that MRI-targeted biopsy improves detection of clinically significant cancer over TRUS-guided biopsy alone, it would suggest that this protocol may be a more practical solution. Moreover, if the results show that MRI-targeted biopsy could reduce the number of cores taken without missing clinically significant cancers, the local biopsy protocol could be adjusted in the future to minimize unnecessary harm in these populations of men. In summary, this study will have practical merits in minimizing costs and patient morbidity associated with unnecessary prostate biopsies and treatments across Canada.
The primary objective of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.
The secondary objectives are to:
- Determine the sensitivity, specificity, positive and negative predictive value of MRI in predicting clinically significant prostate cancer
- Identify areas of the prostate that would benefit most from MRI
- Estimate Type 1 and Type II errors of using MRI-targeted biopsy samples compared to both MRI-targeted and standard 12-core.
- Estimate cost savings by using MRI-targeted biopsy samples only compared to both MRI-targeted and standard 12-core.
- Compare cost-effectiveness of using MRI prior to TRUS-guided biopsy compared to MRI-fusion biopsy used in other centers
This is a prospective, single institution randomized clinical controlled trial.. Participants will be randomized in a 1:1 ratio to one of the following groups:
- Control Group: TRUS-guided systematic 12-core biopsy (standard care)
- Experimental Group: prostate MRI later followed by systematic 12-core TRUS-guided biopsy + targeted biopsy of additional MRI-detected cores
- Conditions
- Prostate Cancer
- Being tested
- TRUS-Guided Biopsy, MRI + TRUS-Guided 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.
TRUS-Guided BiopsyDevice
Also called Transrectal Ultrasound Guided Biopsy
The standard care TRUS-guided biopsy is a schematic 12 core biopsy scheme with 2 cores taken from each of standard 6 zones. In some cases, the radiologist may take additional cores beyond 12 if suspicious areas are suspected from clinical findings or TRUS. TRUS-guided biopsies will be performed by a designated group of radiologists. An overall score out of 5 of likelihood of clinically significant prostate cancer will be recorded for each individual patient. The biopsy will be scheduled within 1 week of referral.
MRI + TRUS-Guided BiopsyDevice
Also called Magnetic Resonance Imaging + MRI-Targeted TRUS-guided Biopsy
A designated radiologist will perform all MRI exams. The radiologist will identify locations of the prostate gland of the standard 12 cores to be taken and any additional lesions deemed to be suspicious for cancer.
The procedure for the MRI-targeted biopsy will be exactly the same as the TRUS-guided biopsy except that an additional 2 cores per area may be taken beyond the standard 12 cores in areas that were previously identified by MRI on the map. The systematic 12-core biopsy will always be performed first. The radiologist performing the MRI-targeted biopsy will review the MRI targets prior to the biopsy as per standard of care, and he/she will also perform the TRUS-guided biopsies for this group. Patients will be scheduled for their biopsy ~ 1 week after the MRI.
| Study group | Role | What they receive |
|---|---|---|
| TRUS-Guided Biopsy | Active comparator | Transrectal Ultrasound (TRUS)-guided biopsy systematic 12-core biopsy (standard care) Receives: Device: TRUS-Guided Biopsy |
| MRI + TRUS-Guided biopsy | Experimental | Prostate MRI later followed by systematic 12-score TRUS-guided biopsy + targeted biopsy of additional MRI-detected scores. Receives: Device: MRI + TRUS-Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Significant Cancer Detection (Biopsy)
- max core length >=3mm (Epstein criteria)
- Gleason score >=3+4 (Epstein criteria)
- clinical Stage T2c (D'Amico criteria)
- Gleason score 6 with >50% involvement of prostate
Measured: participants will be followed until diagnosis, an expected average of 2 weeks
Secondary outcomes (5)
Clinically Significant Cancer Detection (Prostatectomy)
Clinically significant cancer detected at prostatectomy using the same criteria as the primary outcome. Prostatectomy can reveal slightly different outcomes than biopsy so these data will be gathered to determine the true positive and negative predictive value of the MRI using whole-mount specimens.
Measured: Up to 6 months after enrollment
Proportion of Men Who Could Have Potentially Avoided Biopsy
- Determined by specificity and negative predictive values.
- Negative predictive value will be defined as the ratio of patients with a MRI suspicion score ≤2 to patients with clinically insignificant disease.
Measured: participants will be followed until diagnosis, an expected average of 2 weeks
Proportion of Cancers Correctly Identified by MRI
- An MRI cancer risk score of ≥4 for each core will be used to designate a positive test for predicting positive cancer in each core and ≤2 to designate a negative test for predicting no cancer.
Measured: participants will be followed until diagnosis, an expected average of 2 weeks
Proportion of Cancers that would have been Missed
Proportion of cancers that would be have been missed if only cores from targeted biopsy had been taken instead of systematic 12-core biopsy
Measured: participants will be followed until diagnosis, an expected average of 2 weeks
Estimated difference in cost
Estimated difference in cost by using MRI-targets only in biopsy vs systematic 12-core
Measured: participants will be followed until diagnosis, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer St. Onge, PhD, Principal investigator, Research, Regina Qu'Appelle Health RegionAshok Verma, MB, Principal investigator, Radiology, Regina Qu'Applle Health Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488096
- Sponsor's protocol ID
- REB15-27
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2015
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy
- ClinicalTrials.gov ID
- NCT02488096
- Acronym / sponsor ID
- REB15-27
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 2 Jul 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.
The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.
Detailed description
Accurately diagnosing clinically significant prostate cancer at a time when the benefits of treatment outweigh the harm continues to elude clinicians because of the complex nature of prostate cancer. When patients are found to have a high prostate specific antigen (PSA) blood test, an abnormal digital rectal exam, or they have prostate cancer but are delaying treatment (active surveillance), they are referred for transrectal ultrasound (TRUS) guided biopsy. The sensitivity of TRUS with 12-core biopsies is only 53-68% so cancers can be missed, particularly in the anterior region of the prostate. In some cases, TRUS can be used to rule out other causes of abnormal test findings, however the specificity of TRUS is also fairly poor making it difficult for a man to know for certain if he is cancer free. Unfortunately, biopsies also cause serious side effects including incontinence, bowel dysfunction, infection and pain. Increasing the number of cores taken during biopsy does not typically translate to better detection rates.
Magnetic resonance imaging (MRI) has much greater resolution than TRUS and can therefore, detect changes in the prostate more accurately. If conducted prior to a targeted biopsy, MRI can also reduce the number of cores taken compared to a standard biopsy (e.g. 2-4 cores vs. 12 cores), which could reduce biopsy side effects while simultaneously increasing detection of clinically significant cancer compared to routine 12-core biopsies and saving health care system dollars. Technology that combines MRI at the same time as biopsy (MRI-TRUS fusion biopsy) is increasingly being used, with some promising results. However, these techniques require expensive equipment and specially-trained personnel, and are more time-consuming and restrictive in when the procedure can occur. Utilizing MRI prior to a TRUS-guided biopsy could provide the same benefits in terms of cancer detection, but at a more reasonable cost and shorter wait-times as MRI alone can be done in a variety of settings and times.
If the results of this study demonstrate that MRI-targeted biopsy improves detection of clinically significant cancer over TRUS-guided biopsy alone, it would suggest that this protocol may be a more practical solution. Moreover, if the results show that MRI-targeted biopsy could reduce the number of cores taken without missing clinically significant cancers, the local biopsy protocol could be adjusted in the future to minimize unnecessary harm in these populations of men. In summary, this study will have practical merits in minimizing costs and patient morbidity associated with unnecessary prostate biopsies and treatments across Canada.
The primary objective of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.
The secondary objectives are to:
- Determine the sensitivity, specificity, positive and negative predictive value of MRI in predicting clinically significant prostate cancer
- Identify areas of the prostate that would benefit most from MRI
- Estimate Type 1 and Type II errors of using MRI-targeted biopsy samples compared to both MRI-targeted and standard 12-core.
- Estimate cost savings by using MRI-targeted biopsy samples only compared to both MRI-targeted and standard 12-core.
- Compare cost-effectiveness of using MRI prior to TRUS-guided biopsy compared to MRI-fusion biopsy used in other centers
This is a prospective, single institution randomized clinical controlled trial.. Participants will be randomized in a 1:1 ratio to one of the following groups:
- Control Group: TRUS-guided systematic 12-core biopsy (standard care)
- Experimental Group: prostate MRI later followed by systematic 12-core TRUS-guided biopsy + targeted biopsy of additional MRI-detected cores
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUS-Guided Biopsy | Active comparator | Device: TRUS-Guided BiopsyTransrectal Ultrasound (TRUS)-guided biopsy systematic 12-core biopsy (standard care) |
| MRI + TRUS-Guided biopsy | Experimental | Device: MRI + TRUS-Guided BiopsyProstate MRI later followed by systematic 12-score TRUS-guided biopsy + targeted biopsy of additional MRI-detected scores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred for an ultrasound-guided prostate biopsy
- Indication 1: Men without a history of prostate cancer referred to the PAC for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy
- Indication 2: Men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the PAC for a follow-up biopsy
Key exclusion criteria (10 listed)
- Are unable to consent on their own behalf
- Less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding MRI image)
- A history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy)
- Emergent/urgent biopsy referrals
- History of urinary tract infections or prostatitis in the last 3 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-Guided BiopsyAlso: Transrectal Ultrasound Guided BiopsyThe standard care TRUS-guided biopsy is a schematic 12 core biopsy scheme with 2 cores taken from each of standard 6 zones. In some cases, the radiologist may take additional cores beyond 12 if suspicious areas are suspected from clinical findings or TRUS. TRUS-guided biopsies will be performed by a designated group of radiologists. An overall score out of 5 of likelihood of clinically significant prostate cancer will be recorded for each individual patient. The biopsy will be scheduled within 1 week of referral. | Device | TRUS-Guided Biopsy |
| MRI + TRUS-Guided BiopsyAlso: Magnetic Resonance Imaging + MRI-Targeted TRUS-guided BiopsyA designated radiologist will perform all MRI exams. The radiologist will identify locations of the prostate gland of the standard 12 cores to be taken and any additional lesions deemed to be suspicious for cancer. The procedure for the MRI-targeted biopsy will be exactly the same as the TRUS-guided biopsy except that an additional 2 cores per area may be taken beyond the standard 12 cores in areas that were previously identified by MRI on the map. The systematic 12-core biopsy will always be performed first. The radiologist performing the MRI-targeted biopsy will review the MRI targets prior to the biopsy as per standard of care, and he/she will also perform the TRUS-guided biopsies for this group. Patients will be scheduled for their biopsy ~ 1 week after the MRI. | Device | MRI + TRUS-Guided biopsy |
Primary outcome
Clinically Significant Cancer Detection (Biopsy)
Time frame: participants will be followed until diagnosis, an expected average of 2 weeks
* max core length >=3mm (Epstein criteria) * Gleason score >=3+4 (Epstein criteria) * clinical Stage T2c (D'Amico criteria) * Gleason score 6 with >50% involvement of prostate
5 secondary outcomes
Clinically Significant Cancer Detection (Prostatectomy)
Time frame: Up to 6 months after enrollment
Proportion of Men Who Could Have Potentially Avoided Biopsy
Time frame: participants will be followed until diagnosis, an expected average of 2 weeks
Proportion of Cancers Correctly Identified by MRI
Time frame: participants will be followed until diagnosis, an expected average of 2 weeks
Proportion of Cancers that would have been Missed
Time frame: participants will be followed until diagnosis, an expected average of 2 weeks
Estimated difference in cost
Time frame: participants will be followed until diagnosis, an expected average of 2 weeks
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 21 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Jennifer St. Onge, PhD principal investigator
Research, Regina Qu'Appelle Health Region
Ashok Verma, MB principal investigator
Radiology, Regina Qu'Applle Health Region
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-Guided Biopsy and MRI + TRUS-Guided Biopsy in people with Prostate Cancer, run by Saskatchewan Health Authority - Regina Area at 1 site 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 3 inclusion and 10 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 21 Jan 2020. 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 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?
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?
Clinically Significant Cancer Detection (Biopsy) (time frame: participants will be followed until diagnosis, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.