Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.
History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
Intermediate- or high-risk Decipher genomic classifier score
Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.
Patients with neuroendocrine or small cell carcinoma of the prostate
Prior pelvic radiotherapy
History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia
Patients with pN0 or pN1 prostate cancer undergoing postoperative radiotherapy targeting the prostate bed +/- pelvic lymph nodes
Cohort
Prospective
Not listed
Genitourinary Domain Score
To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes.
Gastrointestinal Domain Score
To determine the rate of 2x MCID changes in any gastrointestinal domain score of the patient-reported EPIC-26 QOL tool at any point between baseline and 24 months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Sexual Domain Score
To determine the rate of 2x MCID changes in any sexual domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Change in IPSS Score
To quantify changes in IPSS score at 3 month intervals within the first 12 months of treatment, then at 6 month intervals thereafter until 5 years.
Long-Term Patient Reported GU Symptoms
To quantify long-term patient-reported GU symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.
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