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
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains. SECONDARY OBJECTIVES: I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains. II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxici…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 p…
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 LeaAlbert Lea, Minnesota
- Mayo Clinic Health System-MankatoMankato, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota
- Mayo Clinic Health System-Eau ClaireEau Claire, Wisconsin
- Mayo Clinic Health System-Franciscan HealthcareLa Crosse, Wisconsin