Active Surveillance Magnetic Resonance Imaging Study

Conditions

Prostate Cancer

Keywords

active surveillance, low risk prostate cancer

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.

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.

2019-11-08113 citations

10.1016/j.eururo.2019.10.007

Active Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial.

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.

2018-07-1394 citations

10.1016/j.eururo.2018.06.025

Interventions

DEVICEMRI 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher	one year

Secondary

Measure	Time frame
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher	one year

Countries

Canada

Outcome results

None listed