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

Center Eugene Marquis

Status: Not yet enrolling

Conditions: High Risk Prostate Cancer

Treatments: Procedure: conventional or a moderately hypofractionated; Procedure: Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07189598

2024-2-75-001

Details and patient eligibility

About

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).

Enrollment: 390 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

innovative arm

Experimental group

Description:

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

Treatment:

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 group

Description:

Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week

Treatment:

Procedure: conventional or a moderately hypofractionated