PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
M.D. Anderson Cancer Center
Summary
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
Description
Primary Objectives: Primary Objective #1: To determine the proportion of patients experiencing late grade ≥ 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment. Primary Objective #2: To estimate the change in health-related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT. Patient-reported urinary, bowel, and sexual function and general QoL will be collected using validated EPIC-26, EQ-5D, PROMIS-Fatigue questionnaires prior to RT, at the end of RT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson. 1. cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.) 2. Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10). 3. If Gleason Grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, PSA \>10 ng/mL prior to starting androgen deprivation th…
Interventions
- DeviceStereotactic Body Radiation Therapy
Undergo Radiation Therapy
Location
- MD Anderson Cancer CenterHouston, Texas