Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
NCT ID: NCT06325046
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2024-08-15
2026-08-31
Brief Summary
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Detailed Description
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I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains.
SECONDARY OBJECTIVES:
I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains.
II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
III. To assess and compare patient-reported financial toxicities, using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) assessment tool.
IV. To assess and compare late physician-reported grade ≥ 2 GI and/or GU toxicities of interest within 24 months after SABR using the CTCAE v5.0.
V. To assess and compare change in International Index of Erectile Function (IIEF-15) and International Prostate Symptom Score (IPSS).
VI. To explore the association of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity.
VII. To explore the association of bladder filling on dosimetry, PROs, and toxicity.
VIII. To assess and compare the cumulative incidence of biochemical failure, local progression, distant metastasis, and metastasis-free survival within 60 months after SABR.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo near margin-less adaptive radiation therapy (ART) for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.
ARM II: Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
After completion of study treatment, patients are followed up at months 1, 3, and 6, and then every 6 months for up to 60 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
Computed Tomography
Undergo CT
Cone-Beam Computed Tomography
Undergo CBCT
Image-Guided Adaptive Radiation Therapy
Undergo near margin-less ART
Magnetic Resonance Imaging
Undergo MRI
Survey Administration
Ancillary studies
Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Stereotactic Ablative Radiotherapy
Undergo standard SABR
Survey Administration
Ancillary studies
Interventions
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Computed Tomography
Undergo CT
Cone-Beam Computed Tomography
Undergo CBCT
Image-Guided Adaptive Radiation Therapy
Undergo near margin-less ART
Magnetic Resonance Imaging
Undergo MRI
Stereotactic Ablative Radiotherapy
Undergo standard SABR
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of prostate adenocarcinoma
* National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Ability to complete questionnaire(s) by themselves or with assistance
* Signed informed consent
* Willing to complete requirements for follow-up (during active monitoring phase)
Exclusion Criteria
* Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
* Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
* Metastatic disease by conventional or molecular imaging
* Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
* Concurrent antineoplastic agents (chemotherapy)
* Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
* Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
* Prostate gland volume \> 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score \> 17
* Body weight \> 200 kilogram
* Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Mark R. Waddle, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-01669
Identifier Type: REGISTRY
Identifier Source: secondary_id
GMROR2351
Identifier Type: OTHER
Identifier Source: secondary_id
23-003388
Identifier Type: OTHER
Identifier Source: secondary_id
GMROR2351
Identifier Type: -
Identifier Source: org_study_id
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