NCT06518226Recruiting
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 · Last updated 24 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 5 Jul 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- UMC Utrecht
- Diseases
- Prostate cancer
- NCT number
- NCT06518226
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 28 Mar 2024 to the primary completion date, 1 Jul 2026
- 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
- Metal pelvic implants which cause artefact on MR-imaging sequences
- Previous radical prostatectomy
- Previous pelvic radiotherapy
Other illness
- 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
Other
- Contraindications to MRI
- International Prostate Symptom Score (IPSS) of 15 or higher
- Prostate volume \> 80 cc
Who the study is looking for
- 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)
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.