Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions
2 other identifiers
interventional
144
1 country
5
Brief Summary
This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
5 active sites
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
First Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedStudy Start
First participant enrolled
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2031
March 31, 2026
March 1, 2026
2 years
March 15, 2024
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-related, patient-reported early quality of life (QOL) changes
Will be assessed using the Expanded Prostate Cancer Index Composite (EPIC)-26. The EPIC-26 consists of 13 questions answered on a variety of scales, such as 1-5 where 1=very poor and 5=very good.
Baseline; up to 3 months
Secondary Outcomes (11)
Treatment-related, patient-reported late QOL changes
Baseline; up to 24 months
Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events
Up to 24 months
Change in International Index of Erectile Function (IIEF)
Baseline; up to 24 months
Change in International Prostate Symptom Score (IPSS)
Baseline; up to 24 months
Change in financial adverse events - COST-FACIT
Baseline; 12 months
- +6 more secondary outcomes
Study Arms (2)
Arm I (near margin-less ART)
EXPERIMENTALPatients 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.
Arm II (standard SABR)
ACTIVE COMPARATORPatients 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.
Interventions
Undergo CT
Undergo CBCT
Undergo near margin-less ART
Undergo MRI
Undergo standard SABR
Eligibility Criteria
You may qualify if:
- Gender assigned male at birth: age ≥ 18 years
- 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)
You may not qualify if:
- NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (5)
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark R. Waddle, MD
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 22, 2024
Study Start
August 15, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2031
Last Updated
March 31, 2026
Record last verified: 2026-03