Under construction – not a live service
Sign in
Taking people in CanadaPhase 2/3

Two Radiation Treatments Combined for Favorable-Risk Prostate Cancer

Tests combining two short radiation treatments in men with favorable-risk prostate cancer.

Key facts

Who runs it
Sunnybrook Health Sciences Centre
Where
Toronto, CanadaSee the site
Trial code
Registry title
2 Ablative RadioTherapy Treatments for Prostate Cancer
Status
Recruiting
Phase
Phase 2/3
People taking part
30 people, planned
Started
29 Jul 2020
Expected to end
29 Jul 2028
Type of study
Interventional
Treatments tested
  • SABR + HDR
Record updated
27 June 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with favorable-risk prostate cancer who have not had treatment for it yet. It tests one high-dose brachytherapy treatment combined with one stereotactic radiotherapy treatment.

Sex
Men only
Disease stage
Adenocarcinoma of the prostate confirmed under the microscope, with low risk (T1-T2c, grade group 1, PSA < 10 ng/ml) or favorable intermediate risk (one of T2c, grade group 2, or PSA 10-20 ng/ml, with no more than 50% positive biopsy cores). Prostate volume < 60 cc.
Earlier treatment
No pelvic radiotherapy, prostate surgery (transurethral resection or prostatectomy) or HIFU. No androgen deprivation therapy. 5-alpha-reductase inhibitors are allowed.

Main reasons for not taking part

  • Cancer spread to lymph nodes or distant sites
  • Previous pelvic radiotherapy
  • Previous prostate resection, prostatectomy or HIFU
  • Poor urinary function (IPSS > 15)
  • Cannot have general anaesthesia, or has a condition such as connective tissue disease or inflammatory bowel disease that rules out prostate radiotherapy

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous pelvic radiotherapy
  • Previous transurethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Documented nodal or distant metastases
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthesia

Where in Canada

  • Sunnybrook Health Sciences CentreToronto, CanadaContact: Andrew Loblaw, MD, FRCPCTaking people

About the trial

What the trial wants to find out

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

The group in the trial

  • Intervention ArmTreatment being tested

    Treatment: SABR + HDR

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Plain-language title
Two Radiation Treatments Combined for Favorable-Risk Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 June 2023