Clinical trial · Interventional
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial
- 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)
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are: \- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects? Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care: MRgRT in 5 fractions | Radiation | — | UNRESOLVED |
| Ultrahypofractionated MRgRT in 2 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrahypofractionated MRgRT in 2 fractions
- description
- MRgRT to the prostate in 2 fractions of 12 Gy, with a focal boost of 13.5 Gy to the gross tumor volume (GTV), administered over the course of 8 days.
- interventionNames
- Radiation: Ultrahypofractionated MRgRT in 2 fractions
- type
- ACTIVE_COMPARATOR
- label
- Standard of care: MRgRT in 5 fractions
- description
- MRgRT to the prostate in 5 fractions of 7.25 Gy to the prostate without focal boost, administered over the course of 16-18 days.
- interventionNames
- Radiation: Standard of care: MRgRT in 5 fractions
Primary outcomes (1)
- measure
- Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histopathological confirmation of prostate adenocarcinoma requiring radical treatment * European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of \< 20 ng/ml, Gleason score ≤ 7, cT1c-cT2b/iT3a (non-bulky, \< 20mm) * Written informed consent * Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study * Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) Exclusion Criteria: * Contraindications to MRI * International Prostate Symptom Score (IPSS) of 15 or higher * Prostate volume \> 80 cc * Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease) * Metal pelvic implants which cause artefact on MR-imaging sequences * Previous radical prostatectomy * Previous pelvic radiotherapy * Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin
References
Publications (2)
- BACKGROUNDWestley RL, Biscombe K, Dunlop A, Mitchell A, Oelfke U, Nill S, Murray J, Pathmanathan A, Hafeez S, Parker C, Ratnakumaran R, Alexander S, Herbert T, Hall E, Tree AC. Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):682-687. doi: 10.1016/j.ijrobp.2023.09.032. Epub 2023 Sep 29. PMID 37776979
- DERIVEDLalmahomed TA, Monninkhof EM, van Rijssel MJ, van Melick HHE, Verkooijen HM, de Boer JCJ, van der Voort van Zyp JRN. Two-fraction Ultrahypofractionated Radiotherapy with focal BOost for intermediate-risk, localized prostate cancer (TURBO): study protocol of a phase II, randomized controlled clinical trial. Trials. 2025 Dec 29;26(1):586. doi: 10.1186/s13063-025-09297-5. PMID 41466435