CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
Recruiting · NCT06331013 · Interventional (participants receive a specific treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
CyberKnife ultra-hypofractionated SBRT
What this trial is about
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
Who can take part
Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \> 18 and \< 80 years
- Histologically confirmed adenocarcinoma of the prostate
- Low, Intermediate and high-risk category according to NCCN version 02.2021
- Clinically node negative and no distant metastasis
- Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
- Good urinary flow (peak flow \>10 mL/s) or IPSS \< 15
- Prostate volume \< 100 cc
- Available mpMRI of the prostate
- Less than 3 DILs at mpMRI (if \>2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS \>2)
- Written informed consent for treatment and research purpose
Exclusion criteria
- platelets count \< 75000
- urethral stricture
- Previous pelvic RT
- Concomitant inflammatory bowel disease or other serious systemic comorbidities
- Previous prostatectomy
- Presence of hip prosthesis
Where it is running
1 location listed.
- European Institute of Oncology - Milan, Italy