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Radiation Therapy
SBRT for Prostate Cancer
N/A
Recruiting
Led By Fabio Cury, MD
Research Sponsored by Fabio Cury
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >: 18
International Prostate Symptom Score <16 Prostate gland volume< 80cc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
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.
Who is the study for?
Men over 18 with low to favorable intermediate-risk prostate cancer, a recent PSA under 15 ng/dL, Gleason score of 6 or 7(3+4), and good performance status. They must not have had previous radical prostate treatments, hormonal therapies, or chemotherapy for prostate cancer and should be free from distant metastases and severe health conditions.Check my eligibility
What is being tested?
The trial is testing a one-time Stereotactic Body Radiation Therapy (SBRT) treatment in patients who've had SpaceOAR hydrogel inserted to increase space between the prostate and rectum. It's a phase I study focusing on safety for those with specific types of early-stage prostate cancer.See study design
What are the potential side effects?
While side effects are not detailed here, SBRT may commonly cause urinary issues, bowel discomfort, fatigue, skin reactions in the treated area, erectile dysfunction and might also lead to more serious but rare complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My prostate symptoms are mild and my prostate is small.
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My prostate cancer is confirmed, not very aggressive, and my recent PSA level is below 10.
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
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)
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
Fabio CuryLead Sponsor
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
933,058 Total Patients Enrolled
3 Trials studying Prostate Cancer
736 Patients Enrolled for Prostate Cancer
Fabio Cury, MDPrincipal InvestigatorMcGill University Health Centre- Cedars Cancer Centre
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.I have been mostly active and able to carry on all pre-disease activities without restriction recently.You have had prostate cancer treatment such as surgery, radiation therapy, or hormone therapy in the past.I am older than 18 years.I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or in situ carcinoma.My prostate symptoms are mild and my prostate is small.I am choosing surgery or active monitoring instead of other treatments.My recent PSA level is under 15 ng/dL, or I have a Gleason score of 7(4+3) with a PSA under 10.You have had chemotherapy for prostate cancer in the past or currently have severe health problems that could interfere with the study, such as recent heart attack or hospitalization for heart or lung issues. You also have liver disease with jaundice or coagulation problems. If you have HIV or other immune system problems, you may not be eligible for this study.My prostate cancer is confirmed, not very aggressive, and my recent PSA level is below 10.My cancer has spread to nearby lymph nodes.I haven't taken dutasteride in the last 90 days.I haven't taken finasteride in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Single Fraction SBRT in the treatment of prostate cancer
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.
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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