Prostate Cancer Clinical Trial
— MVPOfficial title:
A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA)
NCT number | NCT02799303 |
Other study ID # | 130-2016 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | June 2020 |
In this open randomized controlled trial, we seek to study whether prostate cancer screening
using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate
of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy)
compared with prostate cancer screening using prostate-specific antigen (PSA).
The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with
subsequent investigations driven by the serum PSA level. This model has proven highly
controversial due to the inability of PSA level to discern between indolent and aggressive
forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended
against PSA screening. Evidence suggests that prostate cancer screening has led to an
increased proportion of men being diagnosed with potentially curable prostate cancer.
However, due to the inability of the PSA level to accurately distinguish patients with
indolent and lethal forms of prostate cancer, it has led to a significant rate of
over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an
increasingly large role in the management of patients with clinically-localized prostate
cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on
active surveillance and staging prior to definitive interventions. MRI-based prostate cancer
risk assessment has been shown to better distinguish between clinically-significant and
insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based
prostate cancer screening and PSA-based prostate cancer screening is warranted.
Status | Recruiting |
Enrollment | 1010 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - age greater than or equal to 50 years old - life expectancy greater than or equal to 10 years, according to the clinical judgement of study investigators Exclusion Criteria: - history of previous prostate biopsy - PSA level measurement within 3 years of recruitment date - abnormal digital rectal examination of the prostate consistent with prostate cancer - history of prostate cancer in one or more first-degree relatives diagnosed at less than 50 years of age - lower urinary tract voiding symptoms (IPSS greater than or equal to 8) - prior or current use of 5-alpha reductase inhibitor medications (finasteride or dutasteride) - patient unable to communicate in English in order to give proper informed consent - claustrophobia or other medical indication which would preclude MRI - any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically-significant prostate cancer | Gleason score greater than or equal to 7 on TRUS prostate biopsy | Within 3 years of randomization | |
Secondary | Clinically-insignificant prostate cancer | Gleason score equal to 6 on TRUS prostate biopsy | Within 3 years of randomizations |
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