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
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Barbara Alicja Jereczek, MD
barbara.jereczek@ieo.it
+39 0257489037
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 60
Treatments
Experimental: CyberKnife SBRT treatment
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov