Evaluating CyberKnife for treating prostate cancer
Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
This study is testing if a special type of radiation treatment called CyberKnife can help men with low to intermediate risk prostate cancer and looks at certain proteins to see how they might affect the results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Male |
| Sponsor | The Greater Poland Cancer Centre Academic / other |
| Locations | 1 site (Poznan, Wielkopolska) |
| Trial ID | NCT03225235 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife technology for men with low to intermediate risk prostate cancer. It focuses on assessing the prognostic and predictive value of specific proteins (PTEN, SMAD4, Cyclin D1, SPP1) in relation to treatment outcomes. Participants will undergo SBRT and their responses will be monitored to determine the therapy's efficacy. The study aims to provide insights into personalized treatment approaches for prostate cancer patients.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 75 with confirmed adenocarcinoma prostate and low to intermediate risk of progression.
Not a fit: Patients with active cancer other than skin cancer or those who have undergone prior surgical or radiotherapy treatments in the pelvic area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored treatment options for patients with prostate cancer.
How similar studies have performed: Other studies have shown promise with similar SBRT approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed \<180 days prior to the randomization date, * completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; * general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1), * belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2), * PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation, * no distant metastases, * signing informed consent, * morphological and biochemical blood parameters within the normal limits. Exclusion Criteria: * the presence of active cancer, except skin cancer preceding period 5 years prior to randomization, * surgical treatment (radical prostatectomy) or RT in the pelvic area, * co-morbidities that may significantly affect the expectancy life of the patients * do not meet the criteria for inclusion.
Where this trial is running
Poznan, Wielkopolska
- Greater Poland Cancer Centre — Poznan, Wielkopolska, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Milecki, PhD., MD — Greater Poland Cancer Centre
- Study coordinator: Piotr Milecki, PhD., MD
- Email: piotr.milecki@wco.pl
- Phone: +48618850878
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.