Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

108

participants targeted

Target at P25-P50 for phase_3

Timeline

86mo left

Started Feb 2025

Longer than P75 for phase_3

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.3 years study duration

Study Progress15%

Feb 2025May 2033

First Submitted

Initial submission to the registry

October 1, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed

4 months until next milestone

Study Start

First participant enrolled

February 2, 2025

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2028

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2033

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

October 1, 2024

Last Update Submit

February 6, 2026

Conditions

Prostate Carcinoma

Outcome Measures

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.
Up to 3 months post-radiotherapy

Study Arms (2)

Arm A (human-driven treatment planning, radiation therapy)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen CollectionProcedure: Magnetic Resonance ImagingRadiation: Photon Beam Radiation TherapyProcedure: Positron Emission TomographyOther: Questionnaire AdministrationRadiation: Radiation Therapy Treatment Planning and Simulation

Arm B (RapidPlan treatment planning, radiation therapy)

EXPERIMENTAL

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.

Interventions

Radiation Therapy Treatment Planning and SimulationRADIATION

Receive human-driven treatment planning

Also known as: Radiation Therapy Treatment Planning/Simulation

Arm A (human-driven treatment planning, radiation therapy)

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection