Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Men only

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.

More Prostate Cancer trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
SexMen only
Enrollment30 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Drugs / interventionsradiation
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedJuly 29, 2020
Main results expectedJanuary 29, 2024
Study endsJuly 29, 2028
Registry record updatedJune 27, 2023
Trial IDNCT04654338 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

  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.