Actively Recruiting
Adaptive Radiation Therapy (ART) Versus Standard Stereotactic Ablative Body Radiotherapy (SABR) for Localized Prostate Cancer: A Randomized Study Comparing Two and Five Treatment Fractions
Led by Mayo Clinic · Updated on 2026-03-31
144
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating quality of life changes after two different radiation treatments for localized prostate cancer in men. The study compares near margin-less adaptive radiation therapy (ART), which uses treatment feedback to adjust future doses and aims to reduce exposure to healthy tissue, with standard stereotactic ablative body radiotherapy (SABR), which delivers radiation in smaller doses over several days. The study focuses on early and late patient-reported quality of life and side effects related to bowel and urinary symptoms, as well as other clinical outcomes. Participants are randomly assigned to one of two groups. One group receives near margin-less ART in two treatments spaced at least three days apart, with imaging procedures including cone beam CT and possibly CT or MRI scans. The other group receives standard SABR in five treatments spaced at least two days apart, also with CT or MRI imaging. Treatment continues as long as there is no disease progression or unacceptable toxicity. Follow-up visits occur at 1, 3, and 6 months after treatment, then every 6 months for up to 5 years. During the study, patients complete questionnaires on quality of life, erectile function, prostate symptoms, and financial impact. Researchers monitor side effects, disease progression, and survival using clinical exams, imaging, and laboratory tests such as PSA levels. The main outcome is patient-reported early quality of life within 3 months after treatment. Long-term monitoring includes up to 5 years of follow-up to assess disease control and side effects. The study aims to identify whether shorter ART treatment can maintain effectiveness while reducing quality of life impacts compared to standard SABR.
CONDITIONS
Brief 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...
- Male gender assigned at birth, aged 18 years or older
- Histological confirmation of prostate adenocarcinoma
- Low- to intermediate-risk prostate adenocarcinoma per NCCN guidelines
- ECOG performance status of 0, 1, or 2
- Ability to complete questionnaires independently or with help
- Signed informed consent
- Willingness to complete follow-up requirements during monitoring phase
You will not qualify if you...
- Very low-, high-, or very high-risk prostate adenocarcinoma per NCCN guidelines
- Prior definitive prostate cancer treatment including radiotherapy, prostatectomy, cryotherapy, or HIFU
- Prior bladder outlet obstruction procedures such as TURP, HoLEP, or TUVRP
- Metastatic disease detected by imaging
- Contraindications to radiation therapy including uncontrolled inflammatory bowel disease, ATM mutation, or Xeroderma pigmentosum mutation
- Current use of antineoplastic chemotherapy
- Previous or concurrent malignancy (except certain skin cancers, indolent lymphoma, or chronic myelogenous leukemia) unless disease-free for 5 or more years
- Medical or psychiatric conditions preventing informed consent or protocol adherence
- Prostate gland volume greater than 80 cc or IPSS score greater than 17
- Body weight over 200 kilograms
- Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 weeks depending on treatment arm and scheduling
Participants receive either near margin-less adaptive radiation therapy (ART) with 2 treatment sessions at least 3 days apart or standard stereotactic ablative body radiotherapy (SABR) with 5 treatment sessions at least 2 days apart, depending on their assigned group. Imaging such as cone beam CT, CT, and/or MRI is performed during treatment.
2 to 5 treatment visits depending on assigned treatment arm
Duration - Up to 60 months
After treatment, participants are monitored for treatment-related quality of life changes and potential side effects. Follow-up visits occur at months 1, 3, and 6, then every 6 months for up to 60 months to assess long-term outcomes and safety.
Visits at months 1, 3, 6, then every 6 months up to 60 months
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
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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