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Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer

RecruitingNAAges 18 Years - anyMaleUMC Utrecht
NCT06518226 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Ultrahypofractionated MRgRT in 2 fractions
  • Standard of care: MRgRT in 5 fractions
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Where

1 site
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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