CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

Prostate Cancer Clinical Trial

— PRO-SPEED  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331013
• Other study ID #: IEO 1872
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Barbara Alicja Jereczek, MD
• Phone: +39 0257489037
• Email: barbara.jereczek[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Evaluation of patient-reported toxicity	Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS	24 months
Primary	Evaluation of patient-reported quality of life	Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire	24 months