Radiation Therapy
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
McGill University Health Centre-Cedars Cancer Centre, Montréal, Canada
Stereotactic Body Radiation Therapy (SBRT)N/ARecruitingLed by Fabio Cury, MDResearch Sponsored by Fabio CuryEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up5 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether it is safe to give one big dose of radiation to the prostate while keeping the rectum healthy by using a hydrogel.
Eligible Conditions
- Prostate Cancer
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
Bladder complications
Small bowel or rectal irritation
Secondary outcome measures
PSA control
To assess late GI and GU toxicity
Side effects data
From 2018 Phase 2 trial • 35 Patients • NCT0136059321%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT
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: Single Fraction SBRT in the treatment of prostate cancerExperimental Treatment1 Intervention
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2014
Completed Phase 2
~660
Find a site
Who is running the clinical trial?
Fabio CuryLead Sponsor
Boston Scientific CorporationIndustry Sponsor
692 Previous Clinical Trials
929,619 Total Patients Enrolled
3 Trials studying Prostate Cancer
736 Patients Enrolled for Prostate Cancer
Fabio Cury, MDPrincipal Investigator
McGill University Health Centre- Cedars Cancer Centre1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are taking part in this medical research?
"Affirmative. Clinicaltrials.gov shows that this clinical investigation, which was originally advertised on November 7th 2018, is currently enrolling participants. A total of 12 individuals are required to be enrolled from a single site."
Answered by AI
Is there currently an opportunity to join this scientific experiment?
"Affirmative. Per the details available on clinicaltrials.gov, this medical experiment began recruiting participants since November 7th 2018 and is still actively looking for volunteers. They need to enrol 12 patients in a single facility."
Answered by AI
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