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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic

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

Qualifiers

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

Treatments tested in this trial

  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Photon Beam Radiation Therapy
  • Positron Emission Tomography
  • Questionnaire Administration
  • Radiation Therapy Treatment Planning and Simulation
  • Radiation Therapy Treatment Planning and Simulation

Treatment groups

108 Participants
are divided into 2 treatment groups

Locations

2
Mayo Clinic in Arizona85259, ScottsdaleArizona, United States
Mayo Clinic in Florida32224-9980, JacksonvilleFlorida, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor