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

Prostate Neoplasm Clinical Trial

— PRECISION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380027
• Other study ID #: DRF-2014-07-146
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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
• TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy

Locations

Country	Name	City	State
United Kingdom	University College Hospitals	London

Sponsors (30)

Lead Sponsor

Collaborator

University College, London

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of men with clinically significant detected		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Proportion of men in MRI arm who avoid biopsy		When MRI results available, at an expected average of 30 days post-MRI
Secondary	Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected		When histology results available, at an expected average of 30 days post-biopsy
Secondary	Proportion of men who go on to definitive treatment for prostate cancer	Definitive treatment can be localised (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic (hormone therapy, chemotherapy)	After treatment decision, at an expected average of 30 days post-biopsy
Secondary	Cancer core length of the most involved biopsy core (maximum cancer core length)	Cancer core length in mm	When histology results available, at an expected average of 30 days post-biopsy
Secondary	Proportion of men with post-biopsy adverse events		30 days post biopsy
Secondary	EQ-5D-5L Quality of Life scores	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.	Baseline, 24 hours post intervention and 30 days post intervention
Secondary	Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading		An expected average of 90 days post-biopsy
Secondary	Cost per diagnosis of cancer		30 days post-biopy
Secondary	Proportion of men with clinically insignificant detected		When histology results available, at an expected average of 30 days post-biopsy