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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03225235

Acronym

CYBERPROST

Enrollment

600

Registered

2017-07-21

Start date

2013-08-26

Completion date

2025-08-31

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, SBRT, Ultrafractionation, CyberKnife

Brief summary

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.

Detailed description

Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.

Interventions

RADIATIONSBRT

hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
survival time without biochemical recurrence,	5 years	Phoenix definition of biochemical failure

Secondary

Measure	Time frame	Description
survival time specific for prostate cancer,	5 years	the period of time from randomization until death from prostate cancer

Other

Measure	Time frame	Description
QoL-EORTC quality of life	5 years	For QoL the EORTC questionnaire (C30 with PR25) is used.

Countries

Poland

Contacts

Primary ContactPiotr Milecki, PhD., MD

piotr.milecki@wco.pl+48618850878

Backup ContactSylwia Krąkowska, MD

sylwia.krakowska@wco.pl+48 61 885 08 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026