NCT01354171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Nov 2011

Typical duration for phase_3 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 14, 2016

Status Verified

March 1, 2012

Enrollment Period

4.8 years

First QC Date

May 13, 2011

Last Update Submit

October 13, 2016

Conditions

Prostate Cancer

Keywords

active surveillancelow risk prostate cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher

    one year

Secondary Outcomes (1)

  • To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher

    one year

Study Arms (2)

TRUS guided biopsy

NO INTERVENTION

MRI Assisted TRUS guided biopsy

EXPERIMENTAL
Device: MRI assisted TRUS guided biopsy

Interventions

MRI assisted TRUS guided biopsyDEVICE

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

MRI Assisted TRUS guided biopsy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

  • 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.

    PMID: 31708295DERIVED

  • 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.

    PMID: 30017404DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Laurence Klotz, MD

    Canadian Urology Research Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2016

Study Completion

December 1, 2017

Last Updated

October 14, 2016

Record last verified: 2012-03

Locations

CA(3)