Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer

Not Applicable

Not yet recruiting

• Conditions: High Risk Prostate Cancer

• Registration Number: NCT07189598
• Lead Sponsor: Center Eugene Marquis

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-11-01
• Primary Completion: 2032-11-01
• Study Completion: 2032-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 390

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 European Quality Of Life -5 Dimensions-5 Levels (EQ-5D-5L) scales
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