Prostate CancerPhase 3ASISTNCT01354171
Active Surveillance Magnetic Resonance Imaging Study
A Phase 3 study testing MRI assisted TRUS guided biopsy in people with Prostate Cancer, run by Canadian Urology Research Consortium at 3 sites in Canada.
Trial summary
This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer. 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 assisted TRUS guided biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2011to 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
- histological confirmation of adenocarcinoma of the prostate
- candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
- Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
- Clinical (diagnostic biopsy) Gleason sum < 6
- PSA < 10.0 ng/ml (ug/L)
Who cannot join
- Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
- Planned anti-androgen therapy
- Inability to undergo TRUS biopsy
- Inability to undergo multi-parametric MRI
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
London Health Sciences Centre
London, Ontario, N6A 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.
- Conditions
- Prostate Cancer
- Being tested
- MRI assisted TRUS guided biopsy
- Keywords
- active surveillance, low risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI assisted TRUS guided biopsyDevice
All subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy
| Study group | Role | What they receive |
|---|---|---|
| TRUS guided biopsy | No intervention | Not described |
| MRI Assisted TRUS guided biopsy | Experimental | Not described Receives: Device: MRI assisted TRUS guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
Measured: one year
Secondary outcomes (1)
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2016
- Study completionDec 2017 (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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Urology Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Eigen
- Responsible party
- Sponsor
- Investigators
- Laurence Klotz, MD, Principal investigator, Canadian Urology Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354171
- Sponsor's protocol ID
- CURC-003
- Acronym
- ASIST
- Status last verified
- Mar 2012
- First submitted
- 13 May 2011
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klotz L, Pond G, Loblaw A, Sugar L, Moussa M, Berman D, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Haider M. Randomized Study of Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-year Postbiopsy Follow-up. Eur Urol. 2020 Mar;77(3):311-317. doi: 10.1016/j.eururo.2019.10.007. Epub 2019 Nov 8.
PubMed 31708295Klotz L, Loblaw A, Sugar L, Moussa M, Berman DM, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Pond GR, Haider M. Active Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial. Eur Urol. 2019 Feb;75(2):300-309. doi: 10.1016/j.eururo.2018.06.025. Epub 2018 Jul 13.
PubMed 30017404
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT01354171
- Acronym / sponsor ID
- ASIST / CURC-003
- Conditions
- Prostate Cancer
- Keywords
- active surveillance, low risk prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Canadian Urology Research ConsortiumUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Eigen
- Study start
- Nov 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 May 2011 (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 is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUS guided biopsy | No intervention | – |
| MRI Assisted TRUS guided biopsy | Experimental | Device: MRI assisted TRUS guided 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)
- histological confirmation of adenocarcinoma of the prostate
- candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
Key exclusion criteria (4 listed)
- Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
- Planned anti-androgen therapy
- Inability to undergo TRUS biopsy
- Inability to undergo multi-parametric 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 |
|---|---|---|
| MRI assisted TRUS guided biopsyAll subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy | Device | MRI Assisted TRUS guided biopsy |
Primary outcome
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
Time frame: one year
1 secondary outcome
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Derived from this study: PubMed 31708295Klotz L, Pond G, Loblaw A, Sugar L, Moussa M, Berman D, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Haider M. Randomized Study of Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-year Postbiopsy Follow-up. Eur Urol. 2020 Mar;77(3):311-317. doi: 10.1016/j.eururo.2019.10.007. Epub 2019 Nov 8.
- Derived from this study: PubMed 30017404Klotz L, Loblaw A, Sugar L, Moussa M, Berman DM, Van der Kwast T, Vesprini D, Milot L, Kebabdjian M, Fleshner N, Ghai S, Chin J, Pond GR, Haider M. Active Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial. Eur Urol. 2019 Feb;75(2):300-309. doi: 10.1016/j.eururo.2018.06.025. Epub 2018 Jul 13.
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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.
Laurence Klotz, MD principal investigator
Canadian Urology Research Consortium
3 sites 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 assisted TRUS guided biopsy in people with Prostate Cancer, run by Canadian Urology Research Consortium at 3 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 5 inclusion and 4 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Results are not available in the source record.
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?
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher (time frame: one 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 NCT01354171, 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 14 Oct 2016; AzTrials last refreshed its copy on 29 Oct 2026.