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CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

RECRUITINGN/ASponsored by European Institute of Oncology
Actively Recruiting
PhaseN/A
SponsorEuropean Institute of Oncology
Started2023-02-20
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06331013

Summary

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.

Eligibility

Age: 18 Years – 80 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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