Clinical trial NCT04175730: Prostate Cancer Detection Screening MRI Protocol
Official title: Prostate Cancer Detection Using a Quantitative Screening MRI Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
Primary purpose: SCREENING

Brief summary: Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.

Detailed description: This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study

Eligibility criteria: Inclusion Criteria:

* Adult men between 18 and 80 years of age
* Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
* Ability to provide informed consent

Exclusion Criteria:

* Prior prostate biopsy
* Prior diagnosis of PCa
* MRI incompatible implanted medical devices or foreign bodies
* Rectal anatomy incompatible with TRUS biopsy
* Life expectancy \<10 years as determined by the treating urologist

Primary outcomes:
measure: Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
timeFrame: 19 months
measure: Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
timeFrame: 19 months
measure: Number of Participants With PI-RADS 4-5 on MRI
timeFrame: 19 months
measure: Number of Participants With PI-RADS <4 MRI
timeFrame: 19 months
measure: Number of Participants That Had Adverse Events
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago Hospital and Ambulatory Clinics
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Michael R Abern, MD
role: PRINCIPAL_INVESTIGATOR
References: