Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06625034

Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer

Led by Mayo Clinic · Updated on 2026-02-10

108

Participants Needed

1

Research Sites

433 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be at least 18 years old
  • Histologically confirmed prostate cancer
  • Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 according to AJCC 8th edition
  • Planned to receive definitive dose radiotherapy to the prostate or prostate bed
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 90 days before enrollment
  • Signed informed consent approved by Institutional Review Board (IRB)
  • Completed all required pre-entry tests within specified time frames
  • Able to start radiation treatment within 180 days of registration
  • Eligibility decisions can be confirmed by the principal investigator with documentation
Not Eligible

You will not qualify if you...

  • Previous pelvic radiation greater than 5 Gy
  • Planned radiotherapy to pelvic lymph nodes
  • Planned brachytherapy of the prostate
  • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis
  • Prior hip replacement or penile implant
  • Major medical, addictive, or psychiatric illness preventing consent, treatment completion, or follow-up
  • Use of indwelling or intermittent urinary catheter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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