Combining two advanced radiation therapies for prostate cancer treatment
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
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 |
| Enrollment | 30 (estimated) |
| Sex | Male |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04654338 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men with histologically confirmed adenocarcinoma of the prostate classified as low or favorable intermediate risk.
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.
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 performed: While combining SABR and HDR is a novel approach, previous studies have shown success with each treatment modality individually in prostate cancer management.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.