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Brachytherapy
Ablative Radiotherapy for Prostate Cancer (EARTH Trial)
Phase 2 & 3
Recruiting
Led By Andrew Loblaw, 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
Favorable risk disease defined as either: Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
Histologically confirmed diagnosis of adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
EARTH Trial Summary
This trial found that combining one MR-guided HDR treatment with one SABR treatment was well tolerated and resulted in favourable treatment outcomes.
Who is the study for?
Men with favorable-risk prostate cancer who have not had previous pelvic radiotherapy, hormone therapy for cancer, or certain prostate procedures. They must be able to undergo MRI scans and have a prostate size less than 60 cc without severe urinary symptoms (IPSS ≤15) or other serious health issues.Check my eligibility
What is being tested?
The trial is testing a combination of two advanced radiation treatments: one high-dose rate (HDR) brachytherapy session and one stereotactic ablative body radiotherapy (SABR) session. The goal is to see if this duo can treat prostate cancer effectively with fewer sessions and side effects.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, urinary issues like increased frequency or urgency, bowel changes such as diarrhea, fatigue, skin reactions in the treated area, and erectile dysfunction.
EARTH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is in the early or favorable intermediate stage.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My prostate is smaller than 60 cc according to imaging tests.
EARTH 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
Acute Toxicities
Secondary outcome measures
Late Toxicities
PSA
QOL
EARTH Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,412 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,608 Patients Enrolled for Prostate Cancer
Andrew Loblaw, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
7 Previous Clinical Trials
510 Total Patients Enrolled
6 Trials studying Prostate Cancer
358 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to lymph nodes or other parts of my body.I have had surgery or HIFU treatment for prostate issues before.I am on hormone therapy for my cancer.I cannot undergo prostate radiotherapy due to certain health conditions like connective tissue or inflammatory bowel disease.My prostate cancer is in the early or favorable intermediate stage.My prostate cancer diagnosis was confirmed through a tissue examination.You are able to have a magnetic resonance imaging (MRI) scan.I have had radiation therapy to my pelvic area before.I have a health condition that makes general anesthesia unsafe for me.My prostate is smaller than 60 cc according to imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently able to enroll in this clinical trial?
"The trial, which was posted on 29 July 2020 and updated on 12 June 2022, is currently seeking patients, according to the information on clinicaltrials.gov."
Answered by AI
To what extent is this clinical trial populated?
"Yes, this is an ongoing clinical trial that is currently recruiting patients. The listing on clinicaltrials.gov shows that the study was first posted on 7/29/2020 and was last updated on 6/12/2022. They are looking for a total of 30 patients at 1 site."
Answered by AI
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