Phase II Trial Of Sparing The Urethra, Pudendal Artery And Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer
This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male patients aged 18 years and older
• In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment
• Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen
• Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy)
• Localized adenocarcinoma of the prostate with the following features:
∙ cT1-T2c
‣ PSA\<20
• Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10
‣ Grade Group 1-3
• Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment
• Prostate volume \<120 cc
⁃ History and physical including a digital rectal exam 90 days prior to registration
⁃ ECOG performance status 0-2
⁃ Be eligible and willing to undergo MRI prostate and pelvis as a component of RT planning
⁃ Bone and soft tissue imaging as clinically indicated (for unfavorable intermediate risk or symptomatic patients only) within 120 days prior to registration
⁃ IPSS score ≤20 at time of initial history and physical with treating radiation oncologist