RecruitingNot ApplicableNCT06831032

Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

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

Sponsor

University Health Network, Toronto

Enrollment

26 participants

Start Date

Jul 7, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma Oligorecurrence Iliac Nodal Disease Para-aortic Lymph Node Metastasis Para-aortic Nodal Disease

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria4

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.

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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)