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Trial record 1 of 1 for:    NCT02936258
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PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures (PRECISE)

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ClinicalTrials.gov Identifier: NCT02936258
Recruitment Status : Unknown
Verified January 2018 by Canadian Urology Research Consortium.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Ontario Institute for Cancer Research
Prostate Cancer Canada
Information provided by (Responsible Party):
Canadian Urology Research Consortium

Tracking Information
First Submitted Date  ICMJE September 28, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date February 22, 2018
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
MRI-The proportion of men with clinically significant cancer (Gleason > 7) [ Time Frame: 1 year ]
To determine whether the proportion of men with clinically significant cancer (Gleason > 7) detected by MRI-targeted biopsy is no less than systematic TRUS guided biopsy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7) [ Time Frame: 1 year ]
    1. The proportion of men with clinically significant cancer (Gleason ≥7) detected by MRI-targeted biopsy is greater than systematic TRUS guided biopsy.
  • Proportion of men in each arm with clinically insignificant cancer [ Time Frame: 1 year ]
  • Proportion of men in each arm with Gleason >4+3 detected. [ Time Frame: 1 year ]
  • Proportion of men in MRI arm who avoid biopsy. [ Time Frame: 1 year ]
  • Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected. [ Time Frame: 1 year ]
  • Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy). [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Biopsy-The proportion of men with clinically significant cancer (Gleason ≥7) [ Time Frame: 1 year ]
    1. The proportion of men with clinically significant cancer (Gleason ≥7) detected by MRI-targeted biopsy is greater than systematic TRUS guided biopsy.
    2. Proportion of men in each arm with clinically insignificant cancer detected.
    3. Proportion of men in each arm with Gleason >4+3 detected.
    4. Proportion of men in MRI arm who avoid biopsy.
    5. Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected.
    6. Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy).
  • Proportion of men in each arm with clinically insignificant cancer [ Time Frame: 1 year ]
  • Proportion of men in each arm with Gleason >4+3 detected. [ Time Frame: 1 year ]
    Proportion of men in each arm with Gleason >4+3 detected
  • Proportion of men in MRI arm who avoid biopsy. [ Time Frame: 1 year ]
    Proportion of men in MRI arm who avoid biopsy.
  • Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected. [ Time Frame: 1 year ]
    Proportion of men in the MRI arm whom the PI-RADS score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected.
  • Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy). [ Time Frame: 1 year ]
    Proportion of men in each arm who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures
Official Title  ICMJE A Phase III Multi-centre Open-label Randomized Controlled Trial of Multi-parametric Magnetic Resonance Imaging (MRI)-Targeted Biopsy Compared to Systematic Trans-rectal Ultrasound (TRUS) Guided Biopsy
Brief Summary The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.
Detailed Description

The standard pathway for prostate cancer diagnosis is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following an elevated PSA. TRUS guidance is performed primarily for anatomic guidance as the ultrasound poorly discriminates between cancerous and non-cancerous tissue. TRUS guided prostate biopsies are concentrated in areas of the peripheral zone, thought to harbor the majority of cancer.

An alternative pathway for prostate cancer diagnosis in men with elevated PSA is to perform multi-parametric magnetic resonance imaging (MPMRI) to localize cancer. This information is used to direct a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar or greater amount of clinically significant cancer than systematic TRUS guided biopsy and has several other potential advantages including: the ability to differentiate between clinically significant and insignificant cancer, reducing unnecessary biopsy and fewer numbers of biopsy cores, reducing biopsy-related side-effects.

A 'clinically insignificant cancer' is cancer that is unlikely to progress or to affect an individual's life expectancy and therefore does not warrant treatment. However when diagnosed with low grade cancer that is likely to be insignificant, a large proportion of subjects request treatment in case a more significant cancer is present. A challenge in this area is that subjects are typically not aware that their cancer is clinically insignificant, and often view the early diagnosis and aggressive treatment they have been subjected to as life-saving.

A prostate cancer detection procedure that differentiates clinically significant cancer from clinically insignificant cancer is therefore a major unmet need.

The potential implications of this trial include:

  • A redefinition of the prostate cancer diagnostic pathway;
  • A reduction in the number of subjects undergoing prostate biopsy;
  • A reduction in the number of biopsy cores taken per subject;
  • A reduction in biopsy-related adverse events including sepsis and pain;
  • A reduction in the over-diagnosis of clinically insignificant prostate cancer;
  • A reduction in the economic burden of diagnosing and treating prostate cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Procedure: Standard of Care
    Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
  • Procedure: MRI
    Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
  • Procedure: MRI Targeted Biopsy
    Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
Study Arms  ICMJE
  • MRI
    Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years.
    Interventions:
    • Procedure: MRI
    • Procedure: MRI Targeted Biopsy
  • Active Comparator: Standard of Care
    Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
    Intervention: Procedure: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In order to be eligible, all inclusion criteria must be met:

  1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy;
  2. ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
  3. Serum PSA ≤ 20ng/ml within 3 months of randomization
  4. Fit to undergo all procedures listed in protocol;
  5. Able to provide written informed consent.

Exclusion Criteria:

  1. Prior prostate biopsy
  2. Prior treatment for prostate cancer
  3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
  4. Contraindication to prostate biopsy
  5. Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
  6. Unfit to undergo any procedures listed in protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936258
Other Study ID Numbers  ICMJE PRECISE Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Plan to share publication
Responsible Party Canadian Urology Research Consortium
Study Sponsor  ICMJE Canadian Urology Research Consortium
Collaborators  ICMJE
  • Ontario Institute for Cancer Research
  • Prostate Cancer Canada
Investigators  ICMJE Not Provided
PRS Account Canadian Urology Research Consortium
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP