About this trial
This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be at least 18 years old
Histologically confirmed prostate cancer
Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed])
Planned definitive dose radiotherapy to the prostate or prostate bed
Disqualifiers
Previous pelvic radiation > 5 Gy
Planned delivery of radiotherapy to pelvic lymph nodes
Planned delivery of brachytherapy of the prostate
Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Photon Beam Radiation Therapy
RadiationUndergo radiation therapy
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy Treatment Planning and Simulation
RadiationReceive human-driven treatment planning
Radiation Therapy Treatment Planning and Simulation
RadiationReceive RapidPlan treatment planning
Treatment groups
Trial outcomes
Primary outcomes
Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)
AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated.
Sponsors and contacts
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