NCT04654338RecruitingPhase 2/3
2 Ablative RadioTherapy Treatments for Prostate Cancer
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Source: ClinicalTrials.gov · Last updated 27 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Nov 2020
- Start date
- 29 Jul 2020
- Primary completion date
- 29 Jan 2024
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04654338
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 30
- From 29 Jul 2020 to the primary completion date, 29 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Previous transurethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
Other illness
- Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
Other
- 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
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.