CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for localized prostate cancer using a technique called CyberKnife Ultra-hypofractionated Stereotactic Body Radiation Therapy (SBRT). The goal is to see how effective this treatment is for patients with different risk levels of prostate cancer, including those who are at intermediate to high risk. The study will include 60 male patients over the next two years, and it focuses on targeting the whole prostate gland while also boosting the treatment to the most affected areas within the prostate.

To participate in the trial, patients need to be between 18 and 80 years old with confirmed prostate cancer and good overall health. They should have a specific type of prostate cancer that is not spread beyond the prostate and have a prostate volume of less than 100 cc. Participants will undergo treatment with the CyberKnife and will need to agree to provide informed consent for both the treatment and the research. Throughout the trial, patients can expect regular check-ins to monitor their health and the effectiveness of the treatment. This study could help improve treatment options for men with prostate cancer in the future.

Gender

MALE

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