Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUMC Utrecht
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Ultrahypofractionated MRgRT in 2 fractions
- Standard of care: MRgRT in 5 fractions
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov