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Radiation
Stereotactic Ablative Radiotherapy for Prostate Cancer (2STAR Trial)
Phase 1 & 2
Waitlist Available
Led By Andrew A Loblaw
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
Histologically confirmed prostate adenocarcinoma (centrally reviewed)
Men >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
2STAR Trial Summary
This trial is investigating a new, more intense way of delivering radiation to prostate cancer patients that minimizes side effects.
Who is the study for?
This trial is for men over 18 with low to intermediate risk prostate cancer, which means a clinical stage T1-2b, Gleason Score ≤7, and PSA <20 ng/mL. Candidates should not be on long-term hormone therapy or anticoagulants that can't be stopped for seed insertion, have no history of pelvic radiotherapy or inflammatory bowel disease, and cannot have a large prostate (>90cm3) or hip prosthesis.Check my eligibility
What is being tested?
The study tests a high-precision radiation technique called Stereotactic Ablative Radiotherapy (SABR), using gold seeds for better targeting. It aims to deliver higher doses of radiation directly to the prostate gland while minimizing exposure to the bladder and rectum. All participants will receive the same dose in two sessions (2STAR).See study design
What are the potential side effects?
Potential side effects include increased exposure of normal organs like the rectum and bladder to radiation which could lead to discomfort or issues related to these organs. However, SABR aims to minimize such risks by precisely targeting the prostate.
2STAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis has been confirmed by a lab test.
Select...
I am a man over 18 years old.
2STAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life
2STAR Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Ablative RadiationExperimental Treatment1 Intervention
Stereotactic Ablative Radiation 26 Gy in 2 fractions, once weekly to prostate
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,647 Total Patients Enrolled
Andrew A LoblawPrincipal InvestigatorSunnybrook Health Sciences Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have inflammatory bowel disease.My prostate cancer diagnosis has been confirmed by a lab test.I am a man over 18 years old.I cannot safely stop my blood thinner for a procedure.I have a bleeding disorder.You have an artificial hip joint.My prostate cancer is at an early stage, with a low Gleason score and PSA level.My prostate is larger than 90cm3 according to scans.I have had radiation therapy to my pelvic area before.I have been on hormone therapy for prostate cancer for more than 6 months.I am not taking any immunosuppressive medications.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Ablative Radiation
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 there any openings for volunteers in this clinical endeavor?
"Going off of the details available at clinicaltrials.gov, this medical trial is not recruiting participants presently. Initially posted in January 2014 and most recently edited on November 2020; however there are 808 other studies that currently need volunteers."
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