Recruiting

ART & SABR

Sponsor:

Mayo Clinic

Code:

NCT06325046

Conditions

Localized Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Cone-Beam Computed Tomography

Image-Guided Adaptive Radiation Therapy

Magnetic Resonance Imaging

Stereotactic Ablative Radiotherapy

Study Details

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.

Conditions

Localized Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Study ID

NCT06325046

Start date

Aug 15, 2024

Status verified date

Oct, 2026

Completion date

Apr 30, 2032

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Treatment-related, patient-reported early quality of life (QOL) changes [ Time Frame: Baseline; up to 3 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

John Yeakel, MD

Mayo Clinic Health System-Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Lydia W. Ng, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mark R. Waddle, M.D.

Mayo Clinic Health System-Eau Claire

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Now Bahar Alam, MD

Mayo Clinic Health System-Franciscan Healthcare

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Abigail L. Stockham, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.