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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Photon Beam Radiation Therapy

    Radiation

    Undergo radiation therapy

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Questionnaire Administration

    Other intervention

    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

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Arm A (human-driven treatment planning, radiation therapy)Active comparator 6 interventions
Group B: Arm B (RapidPlan treatment planning, radiation therapy)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)

AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated.

Time frame
Up to 3 months post-radiotherapy

Secondary outcomes

Other outcomes

Sponsors and contacts

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