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Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Men only

CyberKnife treatment for localized prostate cancer

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

Run by European Institute of Oncology · NCT06331013 · Data updated 2026-11-12

This study is testing if a special type of radiation treatment called CyberKnife can effectively target localized prostate cancer in men who are at intermediate to high risk.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexMen only
Enrollment60 (estimated)
SponsorEuropean Institute of Oncology
Academic / other
Drugs / interventionsRadiation
Locations1 site (Milan)
StatusRecruiting
StartedFebruary 20, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2029
Registry record updatedAugust 28, 2025
Trial IDNCT06331013 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 to 80 with histologically confirmed adenocarcinoma of the prostate and specific risk categories as defined by the NCCN.

Probably not a fit

Patients with certain comorbidities, previous pelvic radiation, or those with urethral stricture may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study aims to evaluate the effectiveness of ultra-hypofractionated CyberKnife Stereotactic Body Radiation Therapy (SBRT) on the whole prostate gland, along with a simultaneous integrated boost to dominant intraprostatic lesions in patients with intermediate to high-risk prostate cancer. The study will enroll 60 patients over two years, involving initial screenings, imaging, and the insertion of gold fiducials for precise targeting. Treatment will consist of delivering a total of 36.25 Gy in five alternate days, with assessments of quality of life and acute toxicity at the end of the treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less invasive option for patients with localized prostate cancer.

How similar studies have gone: Other studies have shown promise with similar approaches, but this specific methodology may be novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • European Institute of Oncology
    Milan, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.