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Adaptive Radiation Therapy for Localized Prostate Cancer

This study is looking at two different radiation treatments for prostate cancer that has not spread. It compares a newer treatment called "near margin-less adaptive radiation therapy (ART)" given in 2 sessions, to the standard treatment called "stereotactic ablative body radiotherapy (SABR)" given in 5 sessions. ART adjusts the radiation during treatment to better target the cancer and potentially reduce side effects. Researchers want to see if ART leads to better quality of life for patients, especially regarding bowel and urinary issues, compared to standard SABR. You might be able to join if you are a man aged 18 or older with localized prostate adenocarcinoma and meet other health criteria.

Study design
This interventional study plans to enroll 144 men. It compares two different radiation therapy approaches.
What's involved
You would undergo procedures like CT scans, MRI scans, and Cone-Beam CT scans, along with either ART or SABR treatments. You would also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be assessed up to 3 months after treatment, and physician-reported side effects will be tracked for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06325046

Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~164 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Computed TomographyCone-Beam Computed TomographyImage-Guided Adaptive Radiation TherapyMagnetic Resonance ImagingStereotactic Ablative RadiotherapySurvey Administration

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-related, patient-reported early quality of life (QOL) changes
Measured over Baseline; up to 3 months

Conditions

Localized Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

5 sites across 2 states
Minnesota3
Wisconsin2

Study leadership

  • Mark R. Waddle, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Treatment-related, patient-reported early quality of life (QOL) changesBaseline; up to 3 months

    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.