NCT06831032

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 7, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2029

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

February 13, 2025

Last Update Submit

March 18, 2026

Conditions

Iliac Nodal DiseasePara-aortic Lymph Node MetastasisPara-aortic Nodal DiseaseOligorecurrenceProstate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Quantify adverse events using CTCAE v5.0

    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.

    2 years

Secondary Outcomes (5)

  • QoL using EPIC questionnaire

    2 years

  • Pain levels using EPIC questionnaire

    2 years

  • Urinary function using EPIC questionnaire

    2 years

  • Bowel function using EPIC questionnaire

    2 years

  • Assessment of adaptive RT approach using dose accumulation

    2 years

Study Arms (1)

SBRT delivered with CBCT-guided online adaptive RT

EXPERIMENTAL

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).

Radiation: Adaptive radiotherapy using SBRT

Interventions

Adaptive radiotherapy using SBRTRADIATION

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)

SBRT delivered with CBCT-guided online adaptive RT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Central Study Contacts

Andrew McPartlin, MD

CONTACT

416-946-4501andrew.mcpartlin@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 17, 2025

Study Start (Estimated)

July 7, 2026

Primary Completion (Estimated)

July 7, 2029

Study Completion (Estimated)

July 7, 2029

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

CA(1)