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NCT Number: NCT06831032

Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Quantify adverse events using CTCAE v5.0

    Time frame: 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

  1. QoL using EPIC questionnaire

    Time frame: 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.

  2. Pain levels using EPIC questionnaire

    Time frame: 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.

  3. Urinary function using EPIC questionnaire

    Time frame: 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.

  4. Bowel function using EPIC questionnaire

    Time frame: 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.

  5. Assessment of adaptive RT approach using dose accumulation

    Time frame: 2 years

    Dosimetric assessment of the CBCT-guided online adaptive RT approach using dose accumulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: EASY

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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