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

Recruiting in Palo Alto (17 mi)

Overseen byAndrew Loblaw, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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

+2 more

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.

+5 more

Participant Groups

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.

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.

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

🇪🇺 Approved in European Union as SABR for: