Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

NCT06831032 — Not applicable, Recruiting, 26 participants, University Health Network, Toronto

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A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)

Registry	NCT06831032, acronym EASY
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	26 (Estimated)
Sponsor	University Health Network, Toronto (Other)
Conditions	Prostate Adenocarcinoma, Iliac Nodal Disease, Para-aortic Lymph Node Metastasis, Para-aortic Nodal Disease, Oligorecurrence
Interventions	Adaptive radiotherapy using SBRT (Radiation)
Dates	start 2026-04-13, primary completion 2029-04-13 (estimated), completion 2029-04-13 (estimated), first posted 2025-02-17, last updated 2026-10-20
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SBRT delivered with CBCT-guided online adaptive RT	Experimental	Radiation: Adaptive radiotherapy using SBRT	Patients will undergo CT guided online adaptive SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25Gy in 5 fractions ENI to PA nodes (+/- pelvic nodes).

Adaptive radiotherapy using SBRT (Radiation): 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)

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Male, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Princess Margaret Cancer Centre	Toronto, Ontario	Canada	Recruiting