Iliac Nodal Disease, Oligorecurrence, Para-aortic Lymph Node Metastasis, Para-aortic Nodal Disease, Prostate Adenocarcinoma
Conditions
Brief summary
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.
Interventions
RADIATIONAdaptive radiotherapy using SBRT
Adaptive 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)
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed prostate adenocarcinoma. 2. Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT. 3. ≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging. 4. ECOG performance status 0-2.
Exclusion criteria
1. Prior radiotherapy to the nodal echelon (PA +/- common iliac). 2. Active secondary malignancy, except for adequately treated non-melanoma skin cancer. 3. Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study. 4. Contraindication to radiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantify adverse events using CTCAE v5.0 | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| QoL using EPIC questionnaire | 2 years | 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 | 2 years | 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 | 2 years | 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 | 2 years | 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. |
| Assessment of adaptive RT approach using dose accumulation | 2 years | Dosimetric assessment of the CBCT-guided online adaptive RT approach using dose accumulation. |
Countries
Canada
Contacts
CONTACTAndrew McPartlin, MD
Outcome results
None listed