MRI Versus PSA in Prostate Cancer Screening

NCT02799303 | Unknown DMC

• 1 other identifier: 130-2016
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 1

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

Keywords

screening; biopsy; magnetic resonance imaging; prostate specific antigen

Outcome Measures

Primary Outcomes (1)

• Clinically-significant prostate cancer

  Gleason score greater than or equal to 7 on TRUS prostate biopsy

  Within 3 years of randomization

Secondary Outcomes (1)

• Clinically-insignificant prostate cancer

  Within 3 years of randomizations

Study Arms (2)

Multi-parametric MRI

EXPERIMENTAL

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

PSA Only

ACTIVE COMPARATOR

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

Interventions

Multi-parametric MRI DEVICE

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.

Multi-parametric MRI

PSA testing OTHER

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

PSA Only

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Nam, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Nam, MD

CONTACT

416-480-5075; robert.nam@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Intervention not a drug/biologic.

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CA (1)