About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Computed Tomography
  • Cone-Beam Computed Tomography
  • Image-Guided Adaptive Radiation Therapy
  • Magnetic Resonance Imaging
  • Stereotactic Ablative Radiotherapy
  • Survey Administration

Treatment groups

144 Participants
are divided into 2 treatment groups

Locations

5
Mayo Clinic Health System in Albert Lea56007, Albert LeaMinnesota, United States
Mayo Clinic Health System-Mankato56001, MankatoMinnesota, United States
Mayo Clinic in Rochester55905, RochesterMinnesota, United States
Mayo Clinic Health System-Eau Claire54701, Eau ClaireWisconsin, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor