This study establishes a cohort of Black and low-income men who are considering active surveillance for their prostate cancer and evaluates what factors affect treatment choice. Active surveillance is a widely accepted prostate cancer management strategy for men with favorable risk. However, Black men choose active surveillance for their prostate cancer less frequently than White men. This study establishes a cohort of Black men with prostate cancer and examines the factors that affect whether or not these patients choose active surveillance.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05424783.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern UniversityStatus: Active
Contact: Adam B. Murphy
University of IllinoisStatus: Active
Contact: Daniel Moreira
University of Illinois College of Medicine - ChicagoStatus: Active
Contact: Peter Gann
John H Stroger Jr Hospital of Cook CountyStatus: Active
Contact: Courtney M.P. Hollowell
Phone: 312-864-5233
Jesse Brown Veterans Affairs Medical CenterStatus: Active
Contact: Roohollah Sharifi
Phone: 312-355-3046
PRIMARY OBJECTIVE:
I. To evaluate if the degree of confirmatory testing (i.e. Engaging Newly Diagnosed Men About Cancer Treatment Options [ENACT] Control, ENACT oncotype DX genomic prostate score [GPS] intervention vs. BLAST GPS + magnetic resonance imaging [MRI] +/- confirmatory prostate biopsy [PB]) is independently associated with the proportion of completion of the active surveillance (AS) PB.
SECONDARY OBJECTIVES:
I. To evaluate if the degree of confirmatory testing (i.e. ENACT Control, ENACT GPS Intervention vs. BLAST GPS + MRI +/- Confirmatory PB) is independently associated with the proportion of men who experience biopsy reclassification.
II. To identify and describe the commonly ranked factors that participants eligible for active surveillance state influenced their prostate cancer treatment choice.
III. To compare the proportion of Black men and non-Black men who complete their active surveillance prostate biopsy within 18 months after receiving GPS assay and prostate MRI in the BLAST cohort.
EXPLORATORY OBJECTIVES:
I. To assess whether race modifies the impact of confirmatory test utilization on adherence to surveillance procedures.
II. To compare the proportion of Black men vs. non-Black men who complete their active surveillance prostate biopsy within 18 months across the three groups: ENACT Control, ENACT GPS Intervention, BLAST cohort.
III. To assess the hazard ratio for Black race (Black vs. non-Black men) in experiencing biopsy reclassification/Gleason grade group increase on active surveillance prostate biopsy during the entire follow up period in each study group (ENACT Control, ENACT GPS Intervention, BLAST Cohort).
OUTLINE: This is an observational study.
Patients complete questionnaires over 30-45 minutes and undergo GPS assay on day 1. Patients undergo standard of care MRI on day 29 and patients may undergo standard of care transrectal ultrasound-guided prostate biopsy on day 36. Patients complete questionnaires on day 36 or 50, and patients may complete questionnaires and may undergo collection of a blood sample on day 180.
After completion of study, patients are followed up at day 351, from days 351-533, and then every 6 months for 2 years.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNorthwestern University
Principal InvestigatorAdam B. Murphy
