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Active Surveillance Magnetic Resonance Imaging Study (ASIST)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
MRI assisted TRUS guided biopsy
Sponsored by
Canadian Urology Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring active surveillance, low risk prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TRUS guided biopsy

MRI Assisted TRUS guided biopsy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2011
Last Updated
October 13, 2016
Sponsor
Canadian Urology Research Consortium
Collaborators
OICR, Eigen
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1. Study Identification

Unique Protocol Identification Number
NCT01354171
Brief Title
Active Surveillance Magnetic Resonance Imaging Study
Acronym
ASIST
Official Title
Active Surveillance Magnetic Resonance Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Urology Research Consortium
Collaborators
OICR, Eigen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
active surveillance, low risk prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRUS guided biopsy
Arm Type
No Intervention
Arm Title
MRI Assisted TRUS guided biopsy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI assisted TRUS guided biopsy
Intervention Description
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
Primary Outcome Measure Information:
Title
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
Time Frame
one year
Secondary Outcome Measure Information:
Title
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
Time Frame
one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Klotz, MD
Organizational Affiliation
Canadian Urology Research Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31708295
Citation
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.
Results Reference
derived
PubMed Identifier
30017404
Citation
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.
Results Reference
derived

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Active Surveillance Magnetic Resonance Imaging Study

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