CyberKnife ultra-hypofractionated SBRT: CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion
Study 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
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of Participants with Acute GU and GI toxicities (RTOG) — 3 months Evaluation of acute genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Number of Participants with Late GU and GI toxicities (RTOG) — 24 months Evaluation of late genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Evaluation of patient-reported toxicity — 24 months Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS
Evaluation of patient-reported quality of life — 24 months Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire
Trial sites (1)
Facility
City
Region
Status
European Institute of Oncology
Milan
Italy
Recruiting
More European Institute of Oncology trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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