Combining two advanced radiation therapies for prostate cancer treatment
Official title: Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Run by Sunnybrook Health Sciences Centre · NCT04654338 · Data updated 2026-11-12
This study is testing if combining two types of radiation therapy can help men with low-risk prostate cancer get better results with fewer treatments and less side effects.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Sex | Men only |
| Enrollment | 30 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | July 29, 2020 |
| Main results expected | January 29, 2024 |
| Study ends | July 29, 2028 |
| Registry record updated | June 27, 2023 |
| Trial ID | NCT04654338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are men with histologically confirmed adenocarcinoma of the prostate classified as low or favorable intermediate risk.
✕Probably not a fit
Patients with documented nodal or distant metastases or those who have undergone previous pelvic radiotherapy are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness and tolerability of combining stereotactic ablative body radiation (SABR) with high-dose rate (HDR) brachytherapy for patients with favorable-risk prostate cancer. The approach aims to reduce the number of treatments while maintaining excellent cancer control rates and minimizing side effects. Patients will undergo imaging and treatment planning, followed by the administration of SABR and HDR therapies, with assessments of treatment outcomes and side effects over time. The study seeks to optimize patient convenience and resource use in prostate cancer treatment.
Why it matters
Potential benefit: If successful, this approach could provide a more convenient and effective treatment option for patients with prostate cancer, potentially reducing treatment duration and side effects.
How similar studies have gone: While combining SABR and HDR is a novel approach, previous studies have shown success with each treatment modality individually in prostate cancer management.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate * 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% * Prostate volume \< 60 cc as determined by US, CT or MRI * Ability to undergo MR imaging * Provide written informed consent Exclusion Criteria: * Documented nodal or distant metastases * Previous pelvic radiotherapy * Previous transurethral resection of prostate, previous prostatectomy or HIFU * Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15 * Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Significant medical co-morbidity rendering patient unsuitable for general anaesthesia
Where it's running
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Andrew Loblaw, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Merrylee McGuffin, MSc
- Email: Merrylee.Mcguffin@sunnybrook.ca
- Phone: 416-480-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.