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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06625034
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Photon Beam Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Radiation Therapy Treatment Planning and Simulation — RADIATION
    Receive human-driven treatment planning
  • Radiation Therapy Treatment Planning and Simulation — RADIATION
    Receive RapidPlan treatment planning

Study Details

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.

Key Dates

Start date
Feb 2, 2025
Status verified
Feb 2026
Primary completion
May 28, 2028
Completion
May 28, 2033

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (human-driven treatment planning, radiation therapy)
    Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
  • Experimental: Arm B (RapidPlan treatment planning, radiation therapy)
    Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

Primary Outcome Measure

Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs) [ Time Frame: Up to 3 months post-radiotherapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Nathan Y. Yu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mayo Clinic in Arizona· Scottsdale, AZ

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