Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
NCT06331013

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

Led by European Institute of Oncology · Updated on 2025-08-28

60

Participants Needed

1

Research Sites

358 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 multiparametric MRI of the prostate
  • Less than 3 dominant intraprostatic lesions on MRI (if >2 lesions, only those with higher PI-RADS and PI-RADS >2 included)
  • Written informed consent for treatment and research purposes
Not Eligible

You will not qualify if you...

  • Platelet count < 75000
  • Urethral stricture
  • Previous pelvic radiation therapy
  • Concomitant inflammatory bowel disease or other serious systemic comorbidities
  • Previous prostatectomy
  • Presence of hip prosthesis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

European Institute of Oncology

Milan, Italy

Actively Recruiting

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Research Team

B

Barbara Alicja Jereczek, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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