Clinical trial · Interventional
2 Ablative RadioTherapy Treatments for Prostate Cancer
Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SABR + HDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- interventionNames
- Radiation: SABR + HDR
Primary outcomes (1)
- measure
- Acute Toxicities
- timeFrame
- 6 months
- description
- Acute GU and GI toxicities according to the NCI CTCAE v4.0
Secondary outcomes (3)
- measure
- Late Toxicities
- timeFrame
- 5 years
- description
- Late GU and GI toxicities according to the NCI CTCAE v4.0
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
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