Active Surveillance Magnetic Resonance Imaging Study (ASIST)
This study is currently recruiting participants.
Verified March 2012 by Canadian Urology Research Consortium
Sponsor:
Canadian Urology Research Consortium
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
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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 May 19, 2013