Adaptive SBRT to para‑aortic and iliac lymph nodes to help prostate cancer responses last longer.

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

This study will try CT-guided, online adaptive SBRT to the tumor and nearby at-risk lymph nodes to see if men with oligorecurrent para‑aortic or common iliac nodal prostate cancer get longer-lasting control.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06831032 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm feasibility trial enrolling men with histologically confirmed prostate adenocarcinoma who have controlled local disease and oligorecurrent para‑aortic and/or common iliac nodal metastases. Eligible patients (≤10 involved nodes within the specified para‑aortic/common iliac regions, ECOG 0–2) will undergo CT-guided online adaptive stereotactic body radiotherapy to visible nodal tumors plus elective SBRT to adjacent at-risk nodal regions. Patients with prior radiotherapy to the same nodal echelon or contraindications to radiation are excluded. Outcomes will focus on feasibility, safety, and durability of nodal control following this elective adaptive SBRT approach.

Who should consider this trial

Good fit: Men with prostate adenocarcinoma who have controlled primary disease and limited (≤10) oligorecurrent para‑aortic and/or common iliac lymph node metastases on PSMA PET or CT/MRI, with ECOG 0–2 and no prior radiotherapy to those nodal regions.

Not a fit: Patients with more extensive nodal or distant metastatic disease, prior radiation to the para‑aortic/iliac nodal echelon, significant comorbidities, or contraindications to radiation are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could extend the duration of nodal disease control and delay the need for systemic therapies, potentially preserving quality of life.

How similar studies have performed: Metastasis-directed SBRT for oligorecurrent prostate cancer has shown promise in delaying progression in other trials, but elective, CT-guided online adaptive SBRT to para‑aortic/iliac nodal regions is a newer and less-tested strategy.

Eligibility criteria

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.

Where this trial is running

Toronto, Ontario

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Andrew McPartlin, MD

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