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NCT06331013Recruiting

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
European Institute of OncologyClinicalTrials.govradiation
Verified
Study focus
Disease/Condition
Prostate Cancer
Drug/Device/Intervention
CyberKnife ultra-hypofractionated SBRT
Study type
Interventional
Intervention type
radiation
Sponsor & location
Primary sponsor
European Institute of Oncology
Location
Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Feb 20, 2023
End date
Dec 31, 2029
Enrollment
60 participants
Primary outcome

Number of Participants with Acute GU and GI toxicities (RTOG),Number of Participants with Late GU and GI toxicities (RTOG),Evaluation of patient-reported toxicity,Evaluation of patient-reported quality of life

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.

ICD-10 classifications
Malignant neoplasm of prostateHyperplasia of prostateDisorder of prostate, unspecifiedOther disorders of prostateCarcinoma in situ: Prostate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06331013
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06331013 through Pure Global AI's free database. This phase not specified trial is sponsored by European Institute of Oncology and is currently Recruiting. The study focuses on Prostate Cancer. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.