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

NCT07189598 | Recruiting DMC

• 1 other identifier: 2024-2-75-001
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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).

Conditions

High Risk Prostate Cancer

Keywords

phase III; stereotactic body radiotherapy; prostate cancer; high-risk; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Biochemical recurrence-free survival

  Up to Year 5

• Metastatic recurrence-free survival

  Up to Year 5

• Overall survival

  Up to Year 5

• Quality of life

  Up to Year 5

• Quality of life

  Up to Year 5

Study Arms (2)

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

Procedure: Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)

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

Procedure: conventional or a moderately hypofractionated

Interventions

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: * 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

innovative arm

conventional or a moderately hypofractionated PROCEDURE

* 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)

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Acceptance of treatment and monitoring modalities

You may not qualify if:

• 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).

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre Eugène Marquis

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Congresses as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Organizations; Health Care Economics and Organizations

Central Study Contacts

Jennifer LE GUEVELOU, DR

CONTACT

0299253000; jennifer.leguevelou@gmail.com

Renaud DE CREVOISIER, PR

CONTACT

0299253000; r.de-crevoisier@rennes.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 24, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-01

Locations

FR (1)