Pilot Study of Using Multi-parametric Magnetic Resonance Imaging for Organ Delineation and Tumor Response Assessment of Prostate Cancer Patients Being Treated With Radiation Therapy
Phase: NA
Conditions: Prostate Cancer
Sponsor: Henry Ford Health System

 
Oﬃcial Title of the Study:   
Pilot study using mulƟ-parametric magneƟc 
resonance imaging for organ delinaƟon and 
tumor response assessment of prostate 
cancer paƟents being treated with radiaƟon 
therapy. 
 
 
NCT number:   
NCT03180398 
 
 
Date of the document:  
March 10, 2023 

StaƟsƟcal Plan 
Sample size has been determined based upon the feasibility and low risk to paƟents, funding, and the 
consideraƟon of the staƟsƟcal power to measure detectable changes in endpoints.  PaƟents will 
complete the Abbreviated EPIC quesƟonnaire in wriƟng, at home or in the clinic, per RadiaƟon Therapy 
Oncology Group guidelines.  Diﬀerences between pre-treatment and post-treatment MR Imaging/EPIC 
scores, age, race, educaƟon, body mass index, prostate volume, and cancer risk (based on prostate-
speciﬁc anƟgen, Gleason score, and T-stage).  p-values < 0.05 will be considered staƟsƟcally signiﬁcant.  
Reported p-values are 2-sided.  A clinically relevant change in HRQOL is deﬁned as a diﬀerence from pre-
treatment to post-treatment that exceeds half of the standard deviaƟon of the pre-treatment value.