Status:
NOT_YET_RECRUITING
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
Lead Sponsor:
Center Eugene Marquis
Conditions:
High Risk Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT07189598
Start Date
November 1 2025
End Date
November 1 2032
Last Update
September 24 2025
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