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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ultrahypofractionated MRgRT in 2 fractions
Radiation2x12 Gy with boost to GTV up to 13.5 Gy
Standard of care: MRgRT in 5 fractions
Radiation5x7.25 Gy
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Ultrahypofractionated MRgRT in 2 fractionsExperimental treatment 1 intervention
Group B: Standard of care: MRgRT in 5 fractionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
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.
Time frame
90 days after treatmentSecondary outcomes
1
Incidence of acute grade >= 2 gastrointestinal (GI) physician-reported toxicity
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.
Time frame
Up to 5 years2
Incidences of late grade >= 2 GU physician-reported toxicity
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.
Time frame
Up to 5 years3
Incidences of acute grade >= 2 GI physician-reported toxicity
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.
Time frame
Up to 5 years4
Oncological treatment related quality of life (QoL)
Oncological treatment related quality of life is captured through the generic European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire(QLQ)-C30. It includes 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov