Active Surveillance Magnetic Resonance Imaging Study (ASIST)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014