NCT06331013 CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
| NCT ID | NCT06331013 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-02-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
Eligibility Criteria
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
Contact & Investigator
Barbara Alicja Jereczek
PRINCIPAL INVESTIGATOR
European Institute of Oncology
Frequently Asked Questions
Who can join the NCT06331013 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06331013 currently recruiting?
Yes, NCT06331013 is actively recruiting participants. Contact the research team at barbara.jereczek@ieo.it for enrollment information.
Where is the NCT06331013 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06331013 clinical trial?
NCT06331013 is sponsored by European Institute of Oncology. The principal investigator is Barbara Alicja Jereczek at European Institute of Oncology. The trial plans to enroll 60 participants.
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