NCT06331013

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
44mo left

Started Feb 2023

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2023Dec 2029

Study Start

First participant enrolled

February 20, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

March 13, 2024

Last Update Submit

August 22, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with Acute GU and GI toxicities (RTOG)

    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)

    3 months

  • Number of Participants with Late GU and GI toxicities (RTOG)

    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)

    24 months

  • Evaluation of patient-reported toxicity

    Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS

    24 months

  • Evaluation of patient-reported quality of life

    Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire

    24 months

Study Arms (1)

CyberKnife SBRT treatment

EXPERIMENTAL

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

Radiation: CyberKnife ultra-hypofractionated SBRT

Interventions

CyberKnife ultra-hypofractionated SBRTRADIATION

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

CyberKnife SBRT treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • platelets count \< 75000
  • urethral stricture
  • Previous pelvic RT
  • Concomitant inflammatory bowel disease or other serious systemic comorbidities
  • Previous prostatectomy
  • Presence of hip prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Barbara Alicja Jereczek

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Alicja Jereczek, MD

CONTACT

+39 0257489037barbara.jereczek@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 26, 2024

Study Start

February 20, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2029

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

IT(1)