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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCenter Eugene Marquis

About this trial

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).

Eligibility criteria

Qualifiers

Male.

Age ≥ 18 years

ECOG (Eastern Cooperative Oncology Group) performance status 0-2

Histologically proven prostate adenocarcinoma, not previously treated

Disqualifiers

Presence of nodal or distant metastases

Stage T4.

Prostate volume > 80 cm3.

IPSS >19/35.

Trial design

Treatments tested in this trial

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

Treatment groups

390 Participants
are divided into 2 treatment groups

Sponsors and collaborators