Prostate AdenocarcinomaEASYNCT06831032
Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response
A study testing Adaptive radiotherapy using SBRT in people with Prostate Adenocarcinoma and Iliac Nodal Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Iliac Nodal Disease, Para-aortic Lymph Node Metastasis
- What is being tested?
- Adaptive radiotherapy using SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 13 Apr 2026to 13 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, 416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca
About this study
Official title: A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)
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
- Being tested
- Adaptive radiotherapy using SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: Adaptive radiotherapy using SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
QoL using EPIC questionnaire
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.
Measured: 2 years
Pain levels using EPIC questionnaire
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.
Measured: 2 years
Urinary function using EPIC questionnaire
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.
Measured: 2 years
Bowel function using EPIC questionnaire
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.
Measured: 2 years
Assessment of adaptive RT approach using dose accumulation
Dosimetric assessment of the CBCT-guided online adaptive RT approach using dose accumulation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start13 Apr 2026
- Primary completion13 Apr 2029 (estimated)
- Study completion13 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831032
- Sponsor's protocol ID
- 24-6066
- Acronym
- EASY
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)
- ClinicalTrials.gov ID
- NCT06831032
- Acronym / sponsor ID
- EASY / 24-6066
- Conditions
- Prostate Adenocarcinoma, Iliac Nodal Disease, Para-aortic Lymph Node Metastasis, Para-aortic Nodal Disease, Oligorecurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 13 Apr 2029 (estimated)
- Study completion
- 13 Apr 2029 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT delivered with CBCT-guided online adaptive RT | Experimental | Radiation: Adaptive radiotherapy using SBRTPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive radiotherapy using SBRTAdaptive 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) | Radiation | SBRT delivered with CBCT-guided online adaptive RT |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive radiotherapy using SBRT in people with Prostate Adenocarcinoma and Iliac Nodal Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew McPartlin, MD (416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify adverse events using CTCAE v5.0 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.