RecruitingPhase 3NCT06625034

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

Sponsor

Mayo Clinic

Enrollment

108 participants

Start Date

Feb 2, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Carcinoma

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of planning radiation therapy for prostate cancer: one uses AI-assisted software (RapidPlan) and the other relies on traditional planning done by human specialists. The goal is to find out if the AI-driven approach produces equally effective and safe treatment plans. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer is at an appropriate stage for radiation therapy (stages T1c through T3b) - You are in good enough health to complete treatment (ECOG performance status 0–2) - You are able to start radiation within 6 months of enrolling **You may NOT be eligible if...** - You have had significant pelvic radiation before (more than 5 Gy) - You are planned to receive radiation to pelvic lymph nodes or brachytherapy - You have active Crohn's disease affecting the rectum or active ulcerative colitis - You have had a prior hip replacement or penile implant - You currently use a urinary catheter Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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