Trial Title:
Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer
NCT ID:
NCT06625034
Condition:
Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Radiation
Intervention name:
Photon Beam Radiation Therapy
Description:
Undergo radiation therapy
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Other name:
External beam radiation therapy using photons (procedure)
Other name:
Photon
Other name:
Photon EBRT
Other name:
Photon External Beam Radiotherapy
Other name:
PHOTON Therapy
Other name:
Radiation, Photon Beam
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Intervention type:
Radiation
Intervention name:
Radiation Therapy Treatment Planning and Simulation
Description:
Receive human-driven treatment planning
Arm group label:
Arm A (human-driven treatment planning, radiation therapy)
Other name:
Radiation Therapy Treatment Planning/Simulation
Intervention type:
Radiation
Intervention name:
Radiation Therapy Treatment Planning and Simulation
Description:
Receive RapidPlan treatment planning
Arm group label:
Arm B (RapidPlan treatment planning, radiation therapy)
Other name:
Radiation Therapy Treatment Planning/Simulation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90
days of enrollment
- Patients must sign Institutional Review Board (IRB) approved study specific informed
consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (radiation) within 180 days of study
registration
- In case of confusion about the eligibility or ineligibility of an individual
patient, the principal investigator (PI) can be used as the arbiter and a note to
file will be added to the subject's regulatory binder to document outcome
Exclusion Criteria:
- 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)
- Prior hip replacement or penile implant
- Major medical, addictive, or psychiatric illness which in the investigator's
opinion, will prevent the consent process, completion of the treatment and/or
interfere with follow-up. (consent by legal authorized representative is not
permitted for this study)
- Indwelling or intermittent urinary catheter use
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Nathan Y. Yu, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
November 30, 2032
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06625034
https://www.mayo.edu/research/clinical-trials
