CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT06331013
- Run by
- European Institute of Oncology
- People needed
- 60
- Starts
- 2023-02-20
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-08-28
Who can join
Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- European Institute of Oncology — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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