Home › Prostate Cancer › NCT06625034
Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer
Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy
Who can join
Ages 18 and older · Men
Full eligibility criteria
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment * Patients must sign Institutional Review Board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests within the specified time frames * Patients must be able to start treatment (radiation) within 180 days of study registration * In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome Exclusion Criteria: * 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) * Prior hip replacement or penile implant * Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study) * Indwelling or intermittent urinary catheter use
About the study
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.
What is being tested
- Biospecimen Collection (procedure)
- Magnetic Resonance Imaging (procedure)
- Photon Beam Radiation Therapy (radiation)
- Positron Emission Tomography (procedure)
- Questionnaire Administration (other)
- Radiation Therapy Treatment Planning and Simulation (radiation)
Sponsor: Mayo Clinic · Participants: 108 · Started: Feb 2, 2025
Contact the study team
- Clinical Trials Referral Office · Phone: 855-776-0015
- Cancer Clinical Trials Referral Office · Phone: 507-293-6386
Official record on ClinicalTrials.gov — NCT06625034
Locations in the U.S.
| Arizona | Mayo Clinic in Arizona, Scottsdale |
| Florida | Mayo Clinic in Florida, Jacksonville (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.