Clinical trial · Interventional
Active Surveillance Magnetic Resonance Imaging Study
NCT01354171CI-TRIAL-00024288ASISTunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI assisted TRUS guided biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- TRUS guided biopsy
- type
- EXPERIMENTAL
- label
- MRI Assisted TRUS guided biopsy
- interventionNames
- Device: MRI assisted TRUS guided biopsy
Primary outcomes (1)
- 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 (1)
- measure
- To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKlotz 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. PMID 31708295
- DERIVEDKlotz 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. PMID 30017404