Recruiting

MRI vs. PSA

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02799303

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

Interventions

Multi-parametric MRI

PSA testing

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT02799303

Start date

Jun, 2016

Status verified date

Sep, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1010 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

PSA testing

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

Primary outcome measure

  • Clinically-significant prostate cancer [ Time Frame: Within 3 years of randomization ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 1, 2019

Last verified

Sep, 2019

Keywords

  • screening
  • biopsy
  • magnetic resonance imaging
  • prostate specific antigen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2019-10-01.