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

Inclusion Criteria9

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 Criteria7

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