High Risk Prostate Cancer
Conditions
Keywords
phase III, stereotactic body radiotherapy, prostate cancer, high-risk, randomized clinical trial
Brief summary
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).
Interventions
PROCEDUREAdaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
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
PROCEDUREconventional or a moderately hypofractionated
* 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)
Sponsors
Center Eugene Marquis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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) : * T3a / T3b (proximal extension only), * and/or ISUP (International Society of Urological Pathology) grade 4-5, * and/or PSA (Prostate-Specific Antigen) 20ng/mL * 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
* Presence of nodal or distant metastases * Stage T4. * Prostate volume \> 80 cm3. * IPSS \>19/35. * Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy) * Previous TransUrethral Resection of the prostate (PTUR)). * Previous pelvic radiotherapy. * Chronic inflammatory bowel disease. * Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL) | Five years after radiotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical recurrence-free survival | Up to Year 5 | defined as the time between date of randomization and date of biochemical recurrence, with biological recurrence defined according to Phoenix criteria. |
| Metastatic recurrence-free survival | Up to Year 5 | 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. |
| Overall survival | Up to Year 5 | Defined as the time from date of randomization to date of death (from any cause) |
| Quality of life | Up to Year 5 | defined with International Prostate Symptoms Score (IPSS) |
| Toxicity (GenitoUrea, GenitoIntestial, sexual) of the experimental arm | Up to Year 5 | graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Countries
France
Contacts
CONTACTJennifer LE GUEVELOU, DR
CONTACTRenaud DE CREVOISIER, PR
Outcome results
None listed