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Clinical Trials in the Netherlands / NCT06518226
Recruiting Not applicable

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

NCT06518226 · tracked via the Priya Life Science Netherlands tracker
Sponsor
UMC Utrecht
Phase
Not applicable
Started
2024-03-28
Last updated
2024-07-24

Condition(s) studied

Prostate CancerProstate AdenocarcinomaLocalized Prostate Carcinoma

Investigational drug(s) / intervention(s)

Ultrahypofractionated MRgRT in 2 fractionsStandard of care: MRgRT in 5 fractions

Ultrahypofractionated MRgRT in 2 fractions: 2x12 Gy with boost to GTV up to 13.5 Gy

Standard of care: MRgRT in 5 fractions: 5x7.25 Gy

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity — 90 days after treatment
    This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Utrecht Utrecht Netherlands Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06518226 on ClinicalTrials.gov ↗ ← All trials in the Netherlands