SABR with Boost for Prostate Cancer

(5STAR-PC Trial)

Overseen By Andrea DeAbreu

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: ADT

Must not be taking: Anticoagulants

Disqualifiers: Prior pelvic radiotherapy, Castrate resistance, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks for SABR, 6-18 months for ADT

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating high-intermediate and high-risk prostate cancer using a special type of radiation therapy called SABR (Stereotactic Ablative Body Radiotherapy). The goal is to determine if delivering radiation in five weekly doses, combined with hormone therapy, is effective and well-tolerated. This approach targets cancer in the prostate and nearby areas. Men with confirmed prostate cancer and certain risk factors, such as a specific PSA level, might be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to innovative treatment strategies for prostate cancer.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are on anticoagulation medication and it's unsafe to stop it for a procedure. It's best to discuss your specific medications with the trial team.

What prior data suggests that this SABR treatment is safe for prostate cancer?

Research has shown that Stereotactic Ablative Body Radiotherapy (SABR) is generally easy for patients to handle when treating prostate cancer. In studies, most patients experienced manageable side effects. SABR is considered as safe as other radiation treatments, such as brachytherapy, which has been used for many years. Serious side effects are rare, but some patients might feel slightly tired or have mild urinary issues. Overall, SABR has proven to be a safe option for many prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Stereotactic Ablative Body Radiotherapy (SABR) for prostate cancer because it offers a more precise and targeted approach than traditional radiation therapies. Unlike standard treatments that can take several weeks, SABR delivers high doses of radiation directly to the prostate and nearby areas in just five weekly sessions. This method not only targets the cancer more accurately but also minimizes damage to surrounding healthy tissues. Additionally, combining SABR with androgen deprivation therapy (ADT) for up to 18 months may enhance its effectiveness, potentially leading to better outcomes for patients.

What evidence suggests that SABR is effective for prostate cancer?

Research has shown that Stereotactic Ablative Body Radiotherapy (SABR) is a promising treatment for prostate cancer. One study found that 96% of patients experienced successful outcomes three years after receiving SABR. Another study involving 344 patients with high-risk prostate cancer treated with SABR also reported positive results. Additionally, administering SABR in 5 sessions with a total dose of 40 Gy is feasible and generally well-tolerated, with few additional side effects. These findings suggest that SABR, which participants in this trial will receive, is an effective treatment option for prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Andrew Loblaw, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

Men with prostate cancer that's not spread beyond the pelvis, who can give consent and fill out health questionnaires. They should have a certain level of disease severity based on tumor size, Gleason score (a measure of cancer aggressiveness), or PSA levels (a blood marker). Men taking strong anticoagulants, with bleeding disorders, hip replacements, prior pelvic radiation, certain other diseases or very poor urinary function cannot join.

Inclusion Criteria

My prostate cancer is high-intermediate risk with at least two of the following: T2c, Gleason 7, or PSA between 10-20ng/ml.

My prostate cancer is high-risk due to its stage, aggressiveness, or PSA levels.

Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

You have difficulty urinating, as indicated by a score higher than 20 on the International Prostate Symptom Score (IPSS).

I have a condition that causes abnormal bleeding.

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions with 6-18 months of ADT

5 weeks for SABR, 6-18 months for ADT

5 visits (in-person) for SABR

Follow-up

Participants are monitored for acute toxicity and biochemical disease-free survival

5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• SABR

Trial Overview The trial is testing a type of targeted radiation therapy called SABR for prostate cancer. It involves five weekly sessions targeting the lymph nodes and prostate at different doses. The treatment is combined with hormone therapy lasting 6-18 months to see if it's effective and tolerable for high-risk patients.

How Is the Trial Designed?

Group I: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 Experimental Treatment 1 Intervention

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

SABR is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Prostate Cure Foundation

Collaborator

Trials

2

Recruited

220+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043737/

Stereotactic ablative body radiotherapy in patients with ... Early outcomes of SABR look very promising. In the pHART3 study, routine biopsies were done 3 years post-treatment. Seventy-one of 74 (96%) of eligible patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125000860

Long-term Oncological Outcomes in the Phase 2 PATRIOT ... This study suggests no significant differences in long-term cancer outcomes between EOD and QW schedules for five-fraction prostate SABR.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11069220/

study protocol for phase II safo trial An individual patient meta-analysis of 344 patients with high-risk prostate cancer treated with SABR has shown promising efficacy [12].

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Conclusions and Relevance Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850025001511

Clinician- and Patient-Reported Outcomes of Stereotactic ... Conclusions. SABR delivering 40 Gy in 5 fractions is feasible and well-tolerated for high-risk prostate cancer, with minimal additional toxicity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6484596/

Long-term Outcomes of Stereotactic Body Radiotherapy for ... Comparative analysis of efficacy and safety of radiation treatment options for low- and intermediate-risk prostate cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052235

Stereotactic ablative body radiotherapy for PSMA-PET/CT ... 213 patients were included for analysis. 41.3 % of SABR was delivered to bone and 49.3 % to nodal metastases, with 28 patients (13.1 %) having ...