Stereotactic Body Radiotherapy for Prostate Cancer

(SECURE Trial)

Overseen By Rachel Glicksman, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must be taking: Systemic therapy

Disqualifiers: Spinal cord compression, radiotherapy contraindication

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Stereotactic Body Radiotherapy (SBRT) alongside current treatments can better control prostate cancer that resists usual hormone treatments. It compares SBRT to the standard approach of changing medications to determine which is more effective at managing the disease. Men with prostate cancer that has spread to fewer than ten locations outside the brain and who are on a stable treatment plan might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications. In fact, it involves staying on your current systemic therapy while receiving the new treatment.

Is there any evidence suggesting that Stereotactic Body Radiation Therapy (SBRT) is likely to be safe for humans?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating prostate cancer. One study found that SBRT had a good safety record, with minor side effects like urinary problems in about 27% of men, compared to 18% with standard radiation therapy. Another study indicated that patients experienced fewer issues with bowel, urinary, and sexual functions after SBRT, suggesting it is well-tolerated.

In clinical trials, a Phase 2 study like this one primarily focuses on safety and how well participants handle the treatment. Although specific data from this trial aren't available, the treatment's progression to Phase 2 suggests that earlier studies have already demonstrated reasonable safety. Overall, SBRT is considered a safe option for treating certain types of prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a targeted approach that minimizes damage to surrounding healthy tissue. Unlike traditional radiation therapies that may require longer treatment periods, SBRT delivers high doses of radiation precisely to cancer sites, potentially reducing treatment times while maintaining effectiveness. This precision allows patients to remain on systemic treatments, potentially enhancing overall treatment outcomes. The ability to efficiently focus on oligoprogressive sites also means less disruption to patients' ongoing cancer management plans.

What evidence suggests that Stereotactic Body Radiotherapy is effective for prostate cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats certain types of prostate cancer. Studies have found that about 83.6% of patients do not experience cancer recurrence within five years, indicating a high success rate. SBRT effectively relieves symptoms without causing severe side effects. While some patients might experience minor urinary issues, the overall safety and effectiveness for high-risk prostate cancer remain positive. In this trial, participants in the experimental arm will receive SBRT to oligoprogressive sites while continuing their current systemic treatments. SBRT's ability to target specific cancer areas while maintaining ongoing treatments makes it a promising option for managing slowly spreading prostate cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Rachel Glicksman, MD

Principal Investigator

Princess Margaret Cancer Centre - University Health Network

Are You a Good Fit for This Trial?

Men with Castrate Resistance Prostate Cancer showing less than 10 sites of metastatic lesions outside the brain, who have been on systemic therapy for over 3 months. Participants must be able to consent, have a performance status score between 0-3 indicating varying levels of daily activity capability, and all cancerous sites must be treatable with SBRT.

Inclusion Criteria

I can understand and agree to the study's details.

I have been diagnosed with prostate adenocarcinoma.

My prostate cancer is resistant to hormonal therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Stereotactic Body Radiotherapy (SBRT) while remaining on current Systemic Therapy or a change in Systemic Therapy as per standard of care

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic control and quality of life assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview This trial is testing if using Stereotactic Body Radiotherapy (SBRT) on all areas of progressing cancer while continuing current systemic therapy improves outcomes compared to the standard practice of changing systemic therapies in men whose prostate cancer has resisted castration treatment.

How Is the Trial Designed?

Group I: Arm 2 - Experimental Experimental Treatment 2 Interventions

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.

Group II: Arm 1 - Standard of Care Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000078

The effectiveness and safety of stereotactic body ... The results show minor, non-significant differences in survival rates compared to conventional fractionation, a type of external radiation, after two and five ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.323

Long-term treatment outcomes from the International Multi ... Conclusions: The safety and efficacy profile of SBRT for high-risk prostate cancer remains favorable at long-term follow-up. ADT of medium ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... Overall, SBRT may offer a higher 5-year bPFS rate of 83.6% and effective symptom relief without severe adverse effects. Additionally, no grade 4 or above ...

4. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Trial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...

5. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/shorter-radiation-improves-patient-experience-but-not-disease-control-for-intermediate-risk-prostate

Shorter radiation improves patient experience but not ... Patients treated with stereotactic body radiation therapy (SBRT) reported fewer declines in bowel, urinary and sexual functioning but were more ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.129

Safety evaluation of stereotactic body radiation therapy ... Ultimately, 84% of patients completed all 6 cycles of 177Lu-PSMA-617 (range 4-6). The median follow-up time was 19.1 months (IQR 15.5-22.4) ...