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Recruiting NCT06831032

Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

No phase Interventional Prostate Adenocarcinoma Iliac Nodal Disease Para-aortic Lymph Node Metastasis Para-aortic Nodal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive radiotherapy using SBRT.
Who it may be relevant to
Registry conditions: Prostate Adenocarcinoma, Iliac Nodal Disease, Para-aortic Lymph Node Metastasis, Para-aortic Nodal Disease. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Radiation Adaptive 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)

Primary outcome measures

  • Quantify adverse events using CTCAE v5.0 [Time frame: 2 years]
Secondary outcome measures (5)
  • QoL using EPIC questionnaire [Time frame: 2 years]
  • Pain levels using EPIC questionnaire [Time frame: 2 years]
  • Urinary function using EPIC questionnaire [Time frame: 2 years]
  • Bowel function using EPIC questionnaire [Time frame: 2 years]
  • Assessment of adaptive RT approach using dose accumulation [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT06831032 · 24-6066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗