NCT06331013

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2024-03-26
• Last updated: 2025-08-28

Locations

1 site across 1 country: Italy