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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
Must not have
Documented nodal or distant metastases
Previous transurethral resection of prostate, previous prostatectomy or HIFU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to lymph nodes or other parts of my body.
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I have had surgery or HIFU treatment for prostate issues before.
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I cannot undergo prostate radiotherapy due to certain health conditions like connective tissue or inflammatory bowel disease.
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I have had radiation therapy to my pelvic area before.
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I have a health condition that makes general anesthesia unsafe for me.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Toxicities
Secondary study objectives
Late Toxicities
PSA
QOL

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: Intervention ArmExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,728 Total Patients Enrolled
31 Trials studying Prostate Cancer
11,655 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

HDR (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04654338 — Phase 2 & 3
Prostate Cancer Research Study Groups: Intervention Arm
Prostate Cancer Clinical Trial 2023: HDR Highlights & Side Effects. Trial Name: NCT04654338 — Phase 2 & 3
HDR (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04654338 — Phase 2 & 3
~6 spots leftby Dec 2025
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