← Back to Search

Radiation

SABR with Boost for Prostate Cancer (5STAR-PC Trial)

N/A

Waitlist Available

Led By Andrew Loblaw, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml

High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL

Must not have

Diagnosis of bleeding diathesis

Prior pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of 5 year follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial found that 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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

SABR may cause side effects like skin irritation in treated areas, fatigue, bowel issues such as diarrhea or discomfort during bowel movements, bladder problems including increased frequency or urgency to urinate and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

My prostate cancer diagnosis has been confirmed by a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition that causes abnormal bleeding.

Select...

I have had radiation therapy to my pelvic area before.

Select...

My cancer has spread beyond the pelvis.

Select...

I cannot undergo intense prostate radiotherapy due to certain health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of 5 year follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of 5 year follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of 5 year follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Toxicity

Secondary study objectives

Biochemical disease-free survival

Economic analysis

Quality of Life outcome

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5Experimental Treatment1 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.

0 / 7Eligibility criteria met