CyberKnife treatment for localized prostate cancer
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 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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT06331013 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with certain comorbidities, previous pelvic radiation, or those with urethral stricture may not benefit from this study.
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 performed: Other studies have shown promise with similar approaches, but this specific methodology may be novel.
Eligibility criteria
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 this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Barbara Alicja Jereczek — European Institute of Oncology
- Study coordinator: Barbara Alicja Jereczek, MD
- Email: barbara.jereczek@ieo.it
- Phone: +39 0257489037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.