RecruitingNot ApplicableNCT06325046

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

ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions


Sponsor

Mayo Clinic

Enrollment

144 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of radiation treatment for prostate cancer called adaptive stereotactic ablative body radiotherapy (SABR). Unlike standard radiation that uses many small doses over weeks, SABR delivers high-dose, very precise radiation in just a few sessions. The "adaptive" part means the treatment is adjusted based on how your body looks each day. Researchers want to see how well this approach controls the cancer while minimizing side effects. **You may be eligible if...** - You were assigned male at birth and are 18 or older - You have been diagnosed with prostate cancer (confirmed by biopsy) - Your cancer is classified as low to intermediate risk - You are in generally good health (able to care for yourself) - You are willing to attend follow-up visits **You may NOT be eligible if...** - Your cancer is very low, high, or very high risk - You have already had prostate cancer treatment (surgery, radiation, cryotherapy, or HIFU) - You've had a prostate procedure to relieve urinary blockage (e.g., TURP) - Your cancer has spread to other parts of the body - You have certain genetic conditions or inflammatory bowel disease - Your prostate is very large (over 80cc on MRI) or you have severe urinary symptoms - You weigh more than 200 kg - You are allergic to certain gel spacers (PEG) or iodine used during treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo CT

PROCEDURECone-Beam Computed Tomography

Undergo CBCT

RADIATIONImage-Guided Adaptive Radiation Therapy

Undergo near margin-less ART

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREStereotactic Ablative Radiotherapy

Undergo standard SABR

OTHERSurvey Administration

Ancillary studies


Locations(5)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health System-Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

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NCT06325046


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