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 Cury

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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 • NCT01360593
21%
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 Centre
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04004312 — N/A
Prostate Cancer Research Study Groups: Single Fraction SBRT in the treatment of prostate cancer
Prostate Cancer Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT04004312 — N/A
SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04004312 — N/A

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
Recent research and studies
~2 spots leftby Sep 2024