Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI Versus PSA in Prostate Cancer Screening (MVP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02799303
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Robert Nam, Sunnybrook Health Sciences Centre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Multi-parametric MRI Other: PSA testing Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1010 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention not a drug/biologic.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multi-parametric MRI
Patients from the general population without history of previous prostate biopsy will be allocated to receive mpMRI in order to evaluate for risk of prostate cancer.
Device: Multi-parametric MRI
Non contrast magnetic resonance imaging using T1/T2 weighting, DWI and ADC will be performed. MRI images will be reviewed by a single uro-radiologist and assessed using the PiRADs standards.

Active Comparator: PSA Only

Patients from the general population without history of previous prostate biopsy will be allocated to receive serum PSA testing in order to evaluate for risk of prostate cancer.

Patients with a serum PSA level less than 4.0 ng/mL will be managed expectantly with results provided to their primary care physician.

Other: PSA testing
Serum prostate specific antigen (PSA) testing will be performed using a standardized laboratory assay.




Primary Outcome Measures :
  1. Clinically-significant prostate cancer [ Time Frame: Within 3 years of randomization ]
    Gleason score greater than or equal to 7 on TRUS prostate biopsy


Secondary Outcome Measures :
  1. Clinically-insignificant prostate cancer [ Time Frame: Within 3 years of randomizations ]
    Gleason score equal to 6 on TRUS prostate biopsy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02799303


Contacts
Layout table for location contacts
Contact: Robert Nam, MD 416-480-5075 robert.nam@sunnybrook.ca

Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Mala Singh    4164806100 ext 7504    mala.singh@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Layout table for investigator information
Principal Investigator: Robert Nam, MD Sunnybrook Health Sciences Centre

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Dr. Robert Nam, Professor of Surgery, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02799303     History of Changes
Other Study ID Numbers: 130-2016
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Robert Nam, Sunnybrook Health Sciences Centre:
screening
biopsy
magnetic resonance imaging
prostate specific antigen

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