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

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

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+