Shorter Radiotherapy Schedule Compared With Standard Care for Localized Prostate Cancer
Tests 2 radiotherapy treatments against standard 5 in adults with localized prostate cancer.
Plain-language title generated from the registry record
Registry title: Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Key facts
- Where
- Utrecht, NetherlandsSee the site
Where in Netherlands
- University Medical Center UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT06518226
- Record updated
- 24 July 2024
- Original description
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:Read full original descriptionShow less
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial
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.
Inclusion: 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: Metal pelvic implants which cause artefact on MR-imaging sequences; Previous radical prostatectomy; Previous pelvic radiotherapy; Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease); Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin; Contraindications to MRI; International Prostate Symptom Score (IPSS) of 15 or higher; Prostate volume > 80 cc.