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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of 5 year follow up
Awards & highlights
5STAR-PC Trial 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.Check my eligibility
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.See study design
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.
5STAR-PC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
5STAR-PC Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Toxicity
Secondary outcome measures
Biochemical disease-free survival
Economic analysis
Quality of Life outcome
+1 more5STAR-PC 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.
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,547 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,563 Patients Enrolled for Prostate Cancer
Prostate Cure FoundationUNKNOWN
1 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Prostate Cancer
144 Patients Enrolled for Prostate Cancer
Andrew Loblaw, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
7 Previous Clinical Trials
465 Total Patients Enrolled
6 Trials studying Prostate Cancer
313 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My prostate cancer is high-intermediate risk with at least two of the following: T2c, Gleason 7, or PSA between 10-20ng/ml.I have had radiation therapy to my pelvic area before.You have a hip replacement.My cancer has spread beyond the pelvis.My prostate cancer is high-risk due to its stage, aggressiveness, or PSA levels.I cannot undergo intense prostate radiotherapy due to certain health conditions.My prostate cancer diagnosis has been confirmed by a lab test.My prostate cancer is resistant to hormone therapy.I cannot safely stop my blood thinner for a procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any recruits currently being accepted for this clinical trial?
"The details on clinicaltrials.gov suggest that this experiment is not actively seeking recruits at the moment, though it was first posted in May 2018 and updated as recently as September 2022. However, there are 1,321 other trials enrolling patients now."
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