Clinical trial NCT01354171: Active Surveillance Magnetic Resonance Imaging Study
Official title: Active Surveillance Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: active surveillance
low risk prostate cancer
Lead sponsor: Canadian Urology Research Consortium
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
name: Eigen
First posted: 2011-05-16
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
timeFrame: one year
Secondary outcomes:
measure: To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
timeFrame: one year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Canadian Urology Research Consortium
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.