PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not? (PRECISION)
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| ClinicalTrials.gov Identifier: NCT02380027 |
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Recruitment Status :
Completed
First Posted : March 5, 2015
Last Update Posted : May 1, 2018
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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 |
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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Active Comparator: TRUS-biopsy arm
Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
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Procedure: TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy |
- Proportion of men with clinically significant detected [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]
- Proportion of men in MRI arm who avoid biopsy [ Time Frame: When MRI results available, at an expected average of 30 days post-MRI ]
- 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 ]
- 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)
- 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
- Proportion of men with post-biopsy adverse events [ Time Frame: 30 days post biopsy ]
- 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.
- Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading [ Time Frame: An expected average of 90 days post-biopsy ]
- Cost per diagnosis of cancer [ Time Frame: 30 days post-biopy ]
- Proportion of men with clinically insignificant detected [ Time Frame: When histology results available, at an expected average of 30 days post-biopsy ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml within the previous 3 months
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Exclusion Criteria:
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
- Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
- Unfit to undergo any procedures listed in protocol
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
| United Kingdom | |
| University College Hospitals | |
| London, United Kingdom | |
| 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 |
| Responsible Party: | Veeru Kasivisvanathan, Study Coordinator, University College, London |
| ClinicalTrials.gov Identifier: | NCT02380027 |
| 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 |
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Prostate biopsy MRI transrectal Detection |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |