Patient selection, study enrollment, and randomization and blinding
low bowel, Prostate
PROSTATE
Patients being evaluated for potential treatment of their PCa with definitive radiotherapy will be informed of their eligibility to participate in this clinical trial. An informed consent form will be provided to all patients considering participation in this clinical for personal review. Patients who agree to participate in the study will sign the informed consent form and be provided with a copy of the signed document. Participants will also have the option to be consented remotely using an electronic version of the informed consent form through the Research Electronic Data Capture (REDCap) platform in accordance with federal, state and local regulations, as applicable.This study will employ a phase II non-inferiority design to compare 5 fractions of ultra-hypofractionated radiotherapy versus 2 fractions of ultra-hypofractionated radiotherapy in the definitive setting for PCa. Subjects will be stratified according to baseline EPIC bowel and urinary domain scores (high bowel score and high urinary score vs. high bowel score and low urinary score vs. low bowel score and high urinary score vs. low bowel score and low urinary score) and treatment country (US vs. other). Participants in each stratum will be randomized to the 25 Gy in 2 fraction or 37.5 Gy in 5 fraction treatment arms in a 1:1 ratio using permuted block randomization with varying block sizes as outlined in trial schema shown in Fig. Trial Schema. Expanded PCa Index Composite (EPIC), EuroQol-5D Index (EQ-5D) and International Prostate Symptom Score (IPSS) quality of life (QOL) surveys are collected at screening, baseline (before or first day of radiotherapy), end of radiotherapy, and at 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month and 60 month follow-up visits. *EPIC score groups determined as: high bowel score > 96, low bowel score ≤ 96, high urinary score > 84, low urinary score ≤ 84. ** GI, gastrointestinal; GU, genitourinary; RT, radiotherapyPatients and study investigators will not be blinded given the types of treatments being evaluated and data management will be performed in online clinical trial database. All trial participants, physicians/ health care providers, data analyzers and symptom assessors will be aware of treatment assignment. Randomization will be communicated by email or phone to treating physician and conveyed to patients in a similar manner.