Active Surveillance Magnetic Resonance Imaging Study (ASIST)

This study is currently recruiting participants.
Verified March 2012 by Canadian Urology Research Consortium
Sponsor:
Collaborators:
OICR
Eigen
Information provided by (Responsible Party):
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT01354171
First received: May 13, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Device: MRI assisted TRUS guided biopsy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Active Surveillance Magnetic Resonance Imaging Study

Resource links provided by NLM:


Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:
  • To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: TRUS guided biopsy Device: MRI 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
Experimental: MRI Assisted TRUS guided biopsy Device: MRI 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354171

Contacts
Contact: Marlene Kebabdjian, BA 416-480-6100 ext 2890 marlene.kebabdjian@sunnybrook.ca
Contact: Irene McNeill, BScPhm 416-480-6100 ext 2431 irene.mcneill@sunnybrook.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Catherine Hildebrand, PhD    519-685-8500 ext 53535    catherine.hildebrand@lhsc.on.ca   
Principal Investigator: Joseph Chin, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian, BA    416-480-6100 ext 2890    marlene.kebabdjian@sunnybrook.ca   
Contact: Irene McNeill, BScPhm    416-480-6100 ext 2431    irene.mcneill@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Karen Hersey, RN    416-946-2155    karen.hersey@uhn.on.ca   
Principal Investigator: Neil Fleshner, MD         
Sponsors and Collaborators
Canadian Urology Research Consortium
OICR
Eigen
Investigators
Principal Investigator: Laurence Klotz, MD Canadian Urology Research Consortium
  More Information

No publications provided

Responsible Party: Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT01354171     History of Changes
Other Study ID Numbers: CURC-003
Study First Received: May 13, 2011
Last Updated: March 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by Canadian Urology Research Consortium:
active surveillance
low risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014