Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
NCT Number: NCT06518226
Acronym: TURBO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer|Prostate Adenocarcinoma|Localized Prostate Carcinoma
Interventions: RADIATION: Ultrahypofractionated MRgRT in 2 fractions|RADIATION: Standard of care: MRgRT in 5 fractions
Sponsor: UMC Utrecht
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-28
Completion Date: 2031-02-01
Locations: University Medical Center Utrecht, Utrecht, 3584 CX, Netherlands

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.

Primary Outcome Measures: 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., 90 days after treatment
Secondary Outcome Measures: 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., Up to 5 years|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., Up to 5 years|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., Up to 5 years|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., Up to 5 years|Patient reported Health related quality of life (HRQoL), Generic patient reported quality of life is captured by the EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'., Up to 5 years|Patient reported prostate cancer-specific quality of life (QoL)., Prostate cancer-specific patient reported quality of life is captured by the tumor specific European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire(QLQ)-C30. The questionnaire consists of functional and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology., Up to 5 years|Biochemical progression free survival (bPFS), Prostate Specific Antigen (PSA) levels in ng/mL will be retrieved from the hospital information system. Biochemical recurrence is defined as serum PSA levels that are 2 ng/mL higher than the nadir PSA achieved after treatment., Up to 5 years