Castrate Resistance Prostate CancerPhase 2SECURENCT06927635
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Systemic therapy in people with Castrate Resistance Prostate Cancer and OligoProgressive Metastatic Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Castrate Resistance Prostate Cancer, OligoProgressive Metastatic Disease
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2025to Jun 2030
- Phase
- Phase 2
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- Castrate Resistance Prostate Cancer
- Radiographic evidence of <10 sites of extra-cranial OP metastatic lesions
- Receiving any line of ST for >3 months
- All sites of OP disease are amenable to and can be safely treated with SBRT
- ECOG performance status 0-3
Who cannot join
- Evidence of spinal cord compression
- Contraindication to radiotherapy
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 Center
Toronto, Ontario, M5G 2M9
Rachel Glicksman, MD, 416-946-4483, rachel.glicksman@rmp.uhn.ca
About this study
Official title: Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).
Read the detailed description
The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Systemic therapy
- Keywords
- systemic therapy, stereotactic body radiation therapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
SBRT will be delivered as per institutional standard.
Systemic therapyOther
Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Systemic therapy |
| Arm 2 - Experimental | Experimental | Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility
Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months).
Measured: Within 18 months of study activation.
Change in Prostate-Specific Antigen (PSA)
Assess by standard PSA blood testing if the proportion of patients having a >50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC.
Measured: Enrollment to 12 months post-enrollment.
Secondary outcomes (6)
Radiographic Local Control of Oligopressive Lesions
Radiographic local control of the index OP lesions will be assessed by treating oncologist.
Measured: Enrollment to 12 months-post enrollment.
Radiographic Distant Control of Oligopressive Lesions
Defined by growth of non-Oligoprogressive metastatic sites and/or the development of new sites of metastatic disease, as assessed by treating oncologist.
Measured: Enrollment to 12-months post-enrollment.
Progression Free Survival (PFS)
Defined as the time from randomization to death from any cause, progression of disease, or date of last follow-up, whichever occurs first. PFS will be assessed by the treating oncologist.
Measured: Enrollment to 12-months post-enrollment.
Time to next Systemic Therapy
Defined as the time from when the study intervention has been commenced until commencement of any next systemic anti-cancer therapy (including a change to best supportive care) or date of last follow up, whichever occurs first, which will be assess by the treating oncologist.
Measured: Enrollment to 12-months post-enrollment.
Differences in Toxicity
Toxicity will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported toxicity differences. Toxicity will be collected using CTCAE v5.0
Measured: Enrollment to 12-months post-enrollment.
Differences in Quality of Life
Quality of Life (QoL) will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported QoL differences. QoL will be collected using the EORTC QLQ-C30 questionnaire.
Measured: Enrollment to 12-months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start8 Jul 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate Resistance Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Glicksman, MD, Principal investigator, Princess Margaret Cancer Centre - University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927635
- Sponsor's protocol ID
- 24-5872
- Acronym
- SECURE
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT06927635
- Acronym / sponsor ID
- SECURE / 24-5872
- Keywords
- systemic therapy, stereotactic body radiation therapy (SBRT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 15 Apr 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 is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).
Detailed description
The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT), Other: Systemic therapyParticipants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time. |
| Arm 2 - Experimental | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Other: Systemic therapyParticipants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- Castrate Resistance Prostate Cancer
- Radiographic evidence of <10 sites of extra-cranial OP metastatic lesions
Key exclusion criteria (2 listed)
- Evidence of spinal cord compression
- Contraindication to radiotherapy
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)SBRT will be delivered as per institutional standard. | Radiation | Arm 1 - Standard of Care, Arm 2 - Experimental |
| Systemic therapyParticipants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment. | Other | Arm 1 - Standard of Care, Arm 2 - Experimental |
Primary outcome
Study Feasibility
Time frame: Within 18 months of study activation.
Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months).
Change in Prostate-Specific Antigen (PSA)
Time frame: Enrollment to 12 months post-enrollment.
Assess by standard PSA blood testing if the proportion of patients having a >50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC.
6 secondary outcomes
Radiographic Local Control of Oligopressive Lesions
Time frame: Enrollment to 12 months-post enrollment.
Radiographic Distant Control of Oligopressive Lesions
Time frame: Enrollment to 12-months post-enrollment.
Progression Free Survival (PFS)
Time frame: Enrollment to 12-months post-enrollment.
Time to next Systemic Therapy
Time frame: Enrollment to 12-months post-enrollment.
Differences in Toxicity
Time frame: Enrollment to 12-months post-enrollment.
Differences in Quality of Life
Time frame: Enrollment to 12-months post-enrollment.
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 7 Jul 2026.
Related trials for Castrate Resistance Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
RecruitingPhase 3
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 2
Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer
Prostate Cancer, Metastatic Prostate Cancer
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.
Rachel Glicksman, MD principal investigator
Princess Margaret Cancer Centre - University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Systemic therapy in people with Castrate Resistance Prostate Cancer and OligoProgressive Metastatic 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 8 inclusion and 2 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 7 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rachel Glicksman, MD (416-946-4501 ext. 4961, rachel.glicksman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: Within 18 months of study activation.). The study lists 2 primary outcomes in all. 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 7 Jul 2026.