Clinical trial · Interventional
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
NCT03225235CI-TRIAL-00043162CYBERPROSTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Stereotactic SBRT
- description
- By assuming a hypofractionated irradiation scheme, it is assumed that between the fractions sublethal radiation damage is being treated and the time factor does not significantly affect RT result. The SBRT fractional dose was determined on the basis of a Biologically Effective Dose (BED) calculation using a linear-square model, which assumes that α / β takes the following values for: * tumor (RS) = 1.5 * Late rectal and bladder complications = 3.0 * early rectal and bladder complications = 10.0.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- survival time without biochemical recurrence,
- timeFrame
- 5 years
- description
- Phoenix definition of biochemical failure
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.