CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr (PRO-SPEED)

European Institute of Oncology

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Radiation: CyberKnife ultra-hypofractionated SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT06331013

IEO 1872

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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