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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 : 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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Standard of Care Procedure: MRI Procedure: MRI Targeted Biopsy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.
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.

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).
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
  3. Proportion of men in each arm with Gleason >4+3 detected. [ Time Frame: 1 year ]
  4. Proportion of men in MRI arm who avoid biopsy. [ Time Frame: 1 year ]
  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. [ Time Frame: 1 year ]
  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). [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936258


Contacts
Contact: Laurence Dr Klotz, MD 416-480-4673 laurence.klotz@sunnybrook.ca
Contact: Marlene Kebabdjian 416-480-6100 ext 2890 marlene.kebabdjian@sunnybrook.ca

Locations
Canada, British Columbia
Vancouver Prostate Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Antonio Hurtado-Coll       ahurtado@prostatecentre.com   
Principal Investigator: Peter Black, MD         
Canada, Ontario
London Health Sciences Centre-Victoria Hospital Recruiting
London, Ontario, Canada, N6A5W9
Contact: Stephanie Horst    519-685-8500 ext 56601    stephanie.horst@lhsc.on.ca   
Principal Investigator: Joseph Chin, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian    416-480-6100 ext 2890    marlene.kebabdjian@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G1X6
Contact: Michael Nesbitt    416-946-4501 ext 6897    michael.nesbitt@uhn.ca   
Principal Investigator: Antonio Finelli, MD         
Canada, Quebec
CIUSSS du Centre-Ouest-de-I'ile-de-Montreal-Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Oleg Loutochin    514-340-8222 ext 21627    oloutochin@jgh.mcgill.ca   
Principal Investigator: Franck Bladou, MD         
Sponsors and Collaborators
Canadian Urology Research Consortium
Ontario Institute for Cancer Research
Prostate Cancer Canada

Responsible Party: Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT02936258     History of Changes
Other Study ID Numbers: PRECISE Trial
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share publication