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Rectal Hydrogel Spacer for Prostate Cancer (FIRST STAR Trial)
N/A
Recruiting
Led By Amandeep Taggar, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying if a hydrogel spacer between prostate and rectum can lower radiation damage and improve bowel quality of life in patients receiving second course of radiation.
Who is the study for?
This trial is for men with prostate cancer that has come back locally and can be seen on scans. They must be able to fill out health questionnaires and agree to join the study. Men are excluded if they have resistant cancer, spread of cancer outside the pelvis, previous high-dose radiation therapy, bleeding disorders, poor urinary function, MRI contraindications or cannot stop blood thinners safely.
What is being tested?
The trial tests a biodegradable gel called SpaceOAR placed between the prostate and rectum during salvage SABR (a type of focused radiation therapy) to reduce bowel side effects and improve quality of life in patients undergoing re-irradiation for recurrent prostate cancer.
What are the potential side effects?
Potential side effects may include discomfort or complications from gel placement procedure, possible increased risk of infection due to an additional procedure, and typical risks associated with radiation such as mild skin reactions or temporary changes in bowel habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of SpaceOAR
Secondary study objectives
Acute Coryza
Biochemical disease-free survival
Health utilities
+3 moreAwards & 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: Study ArmExperimental Treatment1 Intervention
All patients with local recurrence of prostate cancer post irradiation will undergo placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life prior to SABR.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,748 Total Patients Enrolled
31 Trials studying Prostate Cancer
11,675 Patients Enrolled for Prostate Cancer
Amandeep Taggar, MDPrincipal InvestigatorSunnybrook
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is resistant to hormone therapy, with a PSA > 3 ng/ml and low testosterone.I have been diagnosed with a bleeding disorder.I have had intense radiotherapy with doses of 5Gy or more per session.My cancer has spread beyond the pelvis.I am on blood thinners that cannot be safely stopped.My prostate cancer has come back in the same area and has been confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Study Arm
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.