Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625034
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs Human-Driven Planning for Prostate Cancer Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVE
I To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary GU and gastrointestinal GI adverse events at 3 months post-radiotherapy for prostate cancer
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Grade 2 or greater GU and GI toxicity at 3 months Common Terminology Criteria for Adverse Events CTCAE version 5 Ib Quality of life 3 months post-radiotherapy Ic Rate of achieving dose-volume constraints II Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning
OUTLINE Patients are randomized to 1 of 2 arms
ARM A HUMAN-DRIVEN 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 magnetic resonance imaging MRI pre-treatment and blood sample collection and positron emission tomography PET throughout study
ARM B KNOWLEDGE-BASED 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
After completion of study treatment patients are followed up at 3 and 12 months then yearly for up to year 5
I To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary GU and gastrointestinal GI adverse events at 3 months post-radiotherapy for prostate cancer
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Grade 2 or greater GU and GI toxicity at 3 months Common Terminology Criteria for Adverse Events CTCAE version 5 Ib Quality of life 3 months post-radiotherapy Ic Rate of achieving dose-volume constraints II Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning
OUTLINE Patients are randomized to 1 of 2 arms
ARM A HUMAN-DRIVEN 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 magnetic resonance imaging MRI pre-treatment and blood sample collection and positron emission tomography PET throughout study
ARM B KNOWLEDGE-BASED 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
After completion of study treatment patients are followed up at 3 and 12 months then yearly for up to year 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None