CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

NCT ID: NCT06331013

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2029-12-31

Brief 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.

Detailed Description

The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.

Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.

Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.

CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CyberKnife SBRT treatment

CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion

Group Type: EXPERIMENTAL

CyberKnife ultra-hypofractionated SBRT

Intervention Type: RADIATION

CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion

Interventions

CyberKnife ultra-hypofractionated SBRT

CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Alicja Jereczek

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara Alicja Jereczek, MD

Role: CONTACT

barbara.jereczek@ieo.it

+39 0257489037

Facility Contacts

Barbara Alicja Jereczek

Role: primary

Other Identifiers

IEO 1872

Identifier Type: -

Identifier Source: org_study_id