The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
390
The doses delivered will be: * the prostate gland, at a dose of 36.25 Gray, in 5 fractions, * the dominant intraprostatic lesion, up to 50 Gray, in 5 fractions, * seminal vesicles, at a dose of 25 Gray in 5 fractions, * pelvic lymph nodes, at 25 Gray in 5 fractions
* Conventional fractionation includes the prescription of a total dose of 78 Gray in 39 fractions to the prostate gland (and seminal vesicles, in case of T3b disease), and a dose de 50Gy in 25 fractions to pelvic nodal areas. * Moderate hypofractionation includes the prescription of a total dose of 60 Gray to the prostate gland (and seminal vesicles, in case of T3b disease), and 44 Gray to pelvic nodal areas in 20 fractions using a simultaneous integrated boost (SIB)
Centre Eugène Marquis
Rennes, France
RECRUITINGEfficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
The primary endpoint is incremental cost effectiveness ratio (ICER) expressed as the cost for each healthy life-year gained at 5 years, with costs estimated from the National Health Data System (NHDS), overall survival (defined as the time between the 1st day of treatment and death from any cause), and utility estimated from clinical trial data
Time frame: Five years after radiotherapy
Biochemical recurrence-free survival
defined as the time between date of randomization and date of biochemical recurrence, with biological recurrence defined according to Phoenix criteria.
Time frame: Up to Year 5
Metastatic recurrence-free survival
Defined as the time from date of randomization to date of metastatic recurrence, metastatic recurrence being defined as the appearance of a lesion outside the target volume.
Time frame: Up to Year 5
Overall survival
Defined as the time from date of randomization to date of death (from any cause)
Time frame: Up to Year 5
Quality of life
defined with International Prostate Symptoms Score (IPSS)
Time frame: Up to Year 5
Quality of life
Defined with Expanded Prostate Cancer Index Composite (EPIC) score
Time frame: Up to Year 5
Quality of life
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Defined with European Quality Of Life -5 Dimensions-5 Levels (EQ-5D-5L) scales
Time frame: Up to Year 5
Toxicity (GenitoUrea, GenitoIntestial, sexual) of the experimental arm
graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Year 5