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PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not? (PRECISION)

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ClinicalTrials.gov Identifier: NCT02380027
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University Hospital, Lille
Radboud University
London North West Healthcare NHS Trust
Royal Free Hospital NHS Foundation Trust
Sunnybrook Health Sciences Centre
University College London Hospitals
University Ghent
Helsinki University Central Hospital
Jewish General Hospital
University of Roma La Sapienza
Göteborg University
Erasmus Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center
University Hospital Heidelberg
University Hospital, Aachen
Hampshire Hospitals NHS Foundation Trust
The Princess Alexandra Hospital NHS Trust, United Kingdom
San Raffaele University Hospital, Italy
M.D. Anderson Cancer Center
University Hospital Southampton NHS Foundation Trust
University of Oulu
The Whittington Hospital NHS Trust
University Hospital of Cologne
Mayo Clinic
Centro de Urologia Argentina
Weill Medical College of Cornell University
University of Chicago
University Hospital, Bordeaux
Information provided by (Responsible Party):
Veeru Kasivisvanathan, University College, London

Brief Summary:

This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.

We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.


Condition or disease Intervention/treatment Phase
Prostate Neoplasm Device: MRI Procedure: MRI-targeted biopsy Procedure: TRUS-biopsy Phase 3

Detailed Description:

The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for prostate cancer diagnosis in the majority of centres. It has many advantages and can be performed routinely under local anaesthetic in an outpatient setting. However it does have some limitations, including the over-diagnosis of insignificant cancer and the under-diagnosis of significant cancer.

An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.

The potential implications of this trial include:

  • A redefining of the prostate cancer diagnostic pathway
  • A reduction in the number of patients undergoing prostate biopsy
  • A reduction in the number of biopsy cores taken per patient
  • A reduction in biopsy-related sepsis, pain and other side effects
  • A reduction in the over-diagnosis of clinically insignificant prostate cancer
  • A reduction of the economic burden of diagnosing and treating prostate cancer

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
Study Start Date : January 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI-arm
Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
Device: MRI
This will be a multi-parametric MRI of the prostate

Procedure: MRI-targeted biopsy
This will be a biopsy targeted to suspicious areas on the MRI

Active Comparator: TRUS-biopsy arm
Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
Procedure: TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy




Primary Outcome Measures :
  1. Proportion of men with clinically significant detected [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]

Secondary Outcome Measures :
  1. Proportion of men in MRI arm who avoid biopsy [ Time Frame: When MRI results available, at an expected average of 30 days post-MRI ]
  2. Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]
  3. Proportion of men who go on to definitive treatment for prostate cancer [ Time Frame: After treatment decision, at an expected average of 30 days post-biopsy ]
    Definitive treatment can be localised (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic (hormone therapy, chemotherapy)

  4. Cancer core length of the most involved biopsy core (maximum cancer core length) [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]
    Cancer core length in mm

  5. Proportion of men with post-biopsy adverse events [ Time Frame: 30 days post biopsy ]
  6. EQ-5D-5L Quality of Life scores [ Time Frame: Baseline, 24 hours post intervention and 30 days post intervention ]
    EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state.

  7. Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading [ Time Frame: An expected average of 90 days post-biopsy ]
  8. Cost per diagnosis of cancer [ Time Frame: 30 days post-biopy ]
  9. Proportion of men with clinically insignificant detected [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]


Information from the National Library of Medicine

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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:

  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. Serum PSA ≤ 20ng/ml within the previous 3 months
  3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
  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 glomerular filtration rate ≤ 50mls/min)
  4. Contraindication to prostate biopsy
  5. Men in whom artifact would reduce the quality of the MRI
  6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
  7. 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): NCT02380027


Locations
United Kingdom
University College Hospitals
London, United Kingdom
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
University Hospital, Lille
Radboud University
London North West Healthcare NHS Trust
Royal Free Hospital NHS Foundation Trust
Sunnybrook Health Sciences Centre
University College London Hospitals
University Ghent
Helsinki University Central Hospital
Jewish General Hospital
University of Roma La Sapienza
Göteborg University
Erasmus Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center
University Hospital Heidelberg
University Hospital, Aachen
Hampshire Hospitals NHS Foundation Trust
The Princess Alexandra Hospital NHS Trust, United Kingdom
San Raffaele University Hospital, Italy
M.D. Anderson Cancer Center
University Hospital Southampton NHS Foundation Trust
University of Oulu
The Whittington Hospital NHS Trust
University Hospital of Cologne
Mayo Clinic
Centro de Urologia Argentina
Weill Medical College of Cornell University
University of Chicago
University Hospital, Bordeaux
Investigators
Study Chair: Caroline Moore, MD FRCS University College Hospital London and University College London
Study Chair: Mark Emberton, MD FRCS University College Hospital London and University College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Veeru Kasivisvanathan, Study Coordinator, University College, London
ClinicalTrials.gov Identifier: NCT02380027     History of Changes
Other Study ID Numbers: DRF-2014-07-146
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Veeru Kasivisvanathan, University College, London:
Prostate biopsy
MRI
transrectal
Detection

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases