Actively Recruiting
Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
Led by Mayo Clinic · Updated on 2026-03-31
144
Participants Needed
5
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Assigned male at birth and age 18 years or older
- Histological confirmation of prostate adenocarcinoma
- Low- to intermediate-risk prostate adenocarcinoma per NCCN guidelines
- ECOG performance status of 2 or less
- Ability to complete questionnaires with or without assistance
- Signed informed consent
- Willingness to complete follow-up requirements during active monitoring phase
You will not qualify if you...
- Very low-, high-, or very high-risk prostate adenocarcinoma per NCCN guidelines
- Prior definitive prostate cancer treatments including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound
- Prior bladder outlet obstruction procedures such as TURP, HoLEP, or TUVRP
- Metastatic disease confirmed by imaging
- Contraindications to radiation therapy such as uncontrolled inflammatory bowel disease or certain genetic mutations
- Current chemotherapy treatment
- Previous or concurrent malignancies except specified exceptions unless disease-free for at least 5 years
- Medical or psychiatric conditions preventing informed decision-making or protocol adherence
- Prostate gland volume greater than 80 cc or IPSS score over 17
- Body weight over 200 kilograms
- Known allergy or sensitivity to polyethylene glycol or iodine
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Actively Recruiting
2
Mayo Clinic Health System-Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
5
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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