Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)

University Health Network, Toronto

Status: Not yet enrolling

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

Treatments: Radiation: Adaptive radiotherapy using SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT06831032

24-6066

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

SBRT delivered with CBCT-guided online adaptive RT

Experimental group

Description:

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).

Treatment:

Radiation: Adaptive radiotherapy using SBRT