Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06331013
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-13
Brief Title:
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion is the Juice Worth the Squeeze The PRO-SPEED Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-SPEED
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 DILs 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 andor 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 3625 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
Additional staging imaging computed tomography CT andor 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 3625 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None