Active Surveillance Magnetic Resonance Imaging Study

NCT ID: NCT01354171

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TRUS guided biopsy

Group Type NO_INTERVENTION

No interventions assigned to this group

MRI Assisted TRUS guided biopsy

Group Type EXPERIMENTAL

MRI assisted TRUS guided biopsy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ontario Institute for Cancer Research

OTHER

Sponsor Role collaborator

Eigen

OTHER

Sponsor Role collaborator

Canadian Urology Research Consortium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence Klotz, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Urology Research Consortium

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31708295 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30017404 (View on PubMed)

Other Identifiers

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CURC-003

Identifier Type: -

Identifier Source: org_study_id

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