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Status unknownNCT01354171ASISTUpdated Oct 14, 2016

Active Surveillance Magnetic Resonance Imaging Study

A Phase 3 interventional study of MRI assisted TRUS guided biopsy in Prostate Cancer, sponsored by Canadian Urology Research Consortium. Status unknown at 3 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Canadian Urology Research Consortium · Phase 3, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • active surveillance
  • low risk prostate cancer
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In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 250 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Canadian Urology Research Consortium is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • No intervention
    TRUS guided biopsy
  • Experimental
    MRI Assisted TRUS guided biopsy

    Device: MRI assisted TRUS guided biopsy

Interventions

  • DeviceMRI assisted TRUS guided biopsy

    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

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What researchers measure

Primary outcomes

  1. To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher

    Time frame: one year

Secondary outcomes

  1. To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher

    Time frame: one year

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Study locations

3 sites
  • London Health Sciences Centre
    London, Ontario N6A 4G5, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
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References and documents

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 31708295 ↗
  • Klotz 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Sep 2016 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2011
First posted
May 16, 2011
Start
Nov 2011
Primary completionActual
Sep 2016
CompletionEst.
Dec 2017
Last update
Oct 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01354171
Lead sponsor
Canadian Urology Research Consortium
Collaborators
Ontario Institute for Cancer Research, Eigen
Responsible party
Sponsor
First posted
May 16, 2011
Start date
Nov 2011
Primary completion
Sep 2016
Completion
Dec 2017 (estimated)
Last update
Oct 14, 2016

Study contacts

Laurence Klotz, MD
principal investigator · Canadian Urology Research Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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