Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.

The Greater Poland Cancer Centre1 site in 1 country600 target enrollmentAugust 26, 2013

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: The Greater Poland Cancer Centre
Enrollment: 600
Locations: 1
Primary Endpoint: survival time without biochemical recurrence,
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 26, 2013

End Date

August 2025

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

The Greater Poland Cancer Centre

Responsible Party

Sponsor

Eligibility 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.