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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| innovative arm | Experimental | Participants treated with Stereostatic Body RadioTherapy (SBRT) will be administered an adaptative stereostactic, ultra-fractionated radiotherapy every other day, for a total treatment time of 10 days. Total treatment time should not exceed 17 days |
|
| control arm | Active Comparator | Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL) | Procedure | The doses delivered will be:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy 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 | Five years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Year 5 |
| Metastatic recurrence-free survival |
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Inclusion Criteria:
Male.
Age ≥ 18 years
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Histologically proven prostate adenocarcinoma, not previously treated
High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :
Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy
Normal testosterone levels prior to hormone therapy
Ability to give consent for inclusion in the study
Acceptance of treatment and monitoring modalities
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer LE GUEVELOU, DR | Contact | 0299253000 | +33 | jennifer.leguevelou@gmail.com |
| Renaud DE CREVOISIER, PR | Contact | 0299253000 | +33 | r.de-crevoisier@rennes.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Eugène Marquis | Recruiting | Rennes | 35000 | France |
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|
| conventional or a moderately hypofractionated | Procedure |
|
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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.
| Up to Year 5 |
| Overall survival | Defined as the time from date of randomization to date of death (from any cause) | Up to Year 5 |
| Quality of life | defined with International Prostate Symptoms Score (IPSS) | Up to Year 5 |
| Quality of life | Defined with Expanded Prostate Cancer Index Composite (EPIC) score | Up to Year 5 |
| Quality of life | Defined with European Quality Of Life -5 Dimensions-5 Levels (EQ-5D-5L) scales | 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 | Up to Year 5 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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