Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06325046

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here