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Trial Title:
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
NCT ID:
NCT06331013
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
CyberKnife ultra-hypofractionated SBRT
Description:
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation
to the dominant intraprostatic lesion
Arm group label:
CyberKnife SBRT treatment
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Barbara Alicja Jereczek
Start date:
February 20, 2023
Completion date:
December 31, 2029
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331013
