About this trial
This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed prostate adenocarcinoma.
Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.
≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.
ECOG performance status 0-2.
Disqualifiers
Prior radiotherapy to the nodal echelon (PA +/- common iliac).
Active secondary malignancy, except for adequately treated non-melanoma skin cancer.
Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.
Contraindication to radiation.
Trial design
Single group
Treatments tested in this trial
Adaptive radiotherapy using SBRT
RadiationAdaptive External beam radiotherapy using SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25 Gy in 5 fractions ENI to PA nodes (+ common iliac nodes)
Treatment groups
Trial outcomes
Primary outcomes
Quantify adverse events using CTCAE v5.0
Acute toxicities (≤3 months) and long-term toxicities (related to urinary, bowel or sexual function) will be collected and evaluated by the CTCAE v5.0.
Secondary outcomes
QoL using EPIC questionnaire
Quality of life (QOL) will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.
Pain levels using EPIC questionnaire
Pain levels will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.
Urinary function using EPIC questionnaire
Urinary function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.
Bowel function using EPIC questionnaire
Bowel function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.
Sponsors and contacts
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