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Taking people in ItalyNo phase

Tests a short course of focused radiation for localized prostate cancer in adult men

Tests short, focused radiation on the prostate and tumor areas in men.

Plain-language title generated from the registry record
Registry title: CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

Key facts

Where
Milan, ItalySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has not spread to lymph nodes or other organs. It tests short, high-dose CyberKnife radiation to the prostate.

Age
Over 18 and under 80 years
Sex
Men only
Disease stage
Prostate adenocarcinoma confirmed by biopsy, low, intermediate or high risk (NCCN version 02.2021). No lymph node spread and no distant metastasis. Fewer than 3 dominant lesions on prostate MRI. Prostate volume under 100 cc.
Earlier treatment
Must not have had earlier pelvic radiotherapy or prostate surgery (prostatectomy).
Biomarker or test result
Prostate MRI (mpMRI) must be available. Good urinary flow (peak flow over 10 mL/s) or IPSS under 15.

Main reasons for not taking part

  • Platelet count under 75000
  • Urethral stricture
  • Previous pelvic radiotherapy or prostatectomy
  • Inflammatory bowel disease or other serious systemic illness
  • Hip prosthesis

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06331013, who can take part

Where in Italy

  • European Institute of OncologyMilan, ItalyContact: Barbara Alicja JereczekTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
European Institute of Oncology
Trial code
NCT06331013
Record updated
28 August 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Previous pelvic RT; Concomitant inflammatory bowel disease or other serious systemic comorbidities; Previous prostatectomy; platelets count < 75000; urethral stricture; Presence of hip prosthesis.

ClinicalTrials.gov NCT06331013