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.
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
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
Parallel
Computed Tomography
Procedure/SurgeryUndergo CT
Cone-Beam Computed Tomography
Procedure/SurgeryUndergo CBCT
Image-Guided Adaptive Radiation Therapy
RadiationUndergo near margin-less ART
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Stereotactic Ablative Radiotherapy
Procedure/SurgeryUndergo standard SABR
Survey Administration
Other interventionAncillary studies
Treatment-related, patient-reported early quality of life (QOL) changes
Will be assessed using the Expanded Prostate Cancer Index Composite (EPIC)-26. The EPIC-26 consists of 13 questions answered on a variety of scales, such as 1-5 where 1=very poor and 5=very good.
Treatment-related, patient-reported late QOL changes
Will be assessed using the EPIC-26 questionnaire, as described above.
Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events
Incidence of adverse events will be recorded at study visits. An adverse event is defined as any undesirable experience associated with the use of a medical product in a patient.
Change in International Index of Erectile Function (IIEF)
The IIEF consists of 15 questions answered with various scales (e.g., a scale of 5-1 where 5=almost always or always and 1=almost never or never). Possible scores range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Change in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life.Each question is answered on a scale of 0-5 where 0=not at all/none and 5=almost always/5 5times.
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