Active Surveillance Magnetic Resonance Imaging Study (ASIST)

Canadian Urology Research Consortium

Status and phase: Unknown; Phase 3

Conditions: Prostate Cancer

Treatments: Device: MRI assisted TRUS guided biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01354171

CURC-003

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

TRUS guided biopsy

No Intervention group

MRI Assisted TRUS guided biopsy

Experimental group

Treatment:

Device: MRI assisted TRUS guided biopsy