Testing Whether A Novel MRI Imaging Approach Will Find Aggressive Disease before Surgery, which May Help Physicians Decide the Best Treatment Plan for Patients with Newly Diagnosed Prostate Cancer
- Men, age >= 18 years, diagnosed within 120 days prior to registration with prostate cancer for whom definitive surgical treatment is indicated * Note: Patients previously diagnosed with prostate cancer for which surgery is not indicated may be enrolled if they undergo a repeat biopsy (within 120 days prior to registration and for reasons including, but not limited to, discordant biopsy results) that indicates definitive treatment with surgery
- Confirmation of payment, insurance pre-authorization, or Medicare for mpMRI
- Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
- Prior surgical and/or non-surgical treatment for prostate cancer
- Prior hip replacement or other major pelvic surgery
- Unable to obtain confirmation of payment, insurance pre-authorization, or Medicare for mpMRI
I. To estimate the diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score based on local site imaging review of multiparametric (mp)MRI (T2 weighted [2W], diffusion weighted imaging [DWI] and dynamic contrast-enhanced [DCE]) to detect clinically significant prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of clinically significant prostate cancer.
I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.
I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.
EXPLORATORY TOBACCO USE OBJECTIVES:
I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic]) and dose modifications.
II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.
III. To examine quitting behaviors and behavioral counseling/ support and cessation medication utilization.
IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.
Patients undergo mpMRI within 3 months prior to scheduled surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.
Trial Phase Phase II
Trial Type Diagnostic
ECOG-ACRIN Cancer Research Group
Clare M.C. Tempany-Afdhal
- Primary ID EA8171
- Secondary IDs NCI-2017-01997
- Clinicaltrials.gov ID NCT03697148