Recruiting

SBRT

Sponsor:

University Health Network, Toronto

Code:

NCT06831032

Conditions

Prostate Adenocarcinoma

Iliac Nodal Disease

Para-aortic Lymph Node Metastasis

Para-aortic Nodal Disease

Oligorecurrence

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adaptive radiotherapy using SBRT

Study Details

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.

Conditions

Prostate Adenocarcinoma

Iliac Nodal Disease

Para-aortic Lymph Node Metastasis

Para-aortic Nodal Disease

Oligorecurrence

Study ID

NCT06831032

Start date

Jul 7, 2026

Status verified date

Mar, 2026

Completion date

Jul 7, 2029

Anticipated

Primary completion date

Jul 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT delivered with CBCT-guided online adaptive RT

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).

Interventions

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 measure

  • Quantify adverse events using CTCAE v5.0 [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Andrew McPartlin, MD

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

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-23.