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CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

RecruitingNAAges 18 Years - 80 YearsMaleEuropean Institute of Oncology
NCT06331013 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • CyberKnife ultra-hypofractionated SBRT
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Where

1 site
European Institute of Oncology
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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