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

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).

Eligibility

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).

Conditions2

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