Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer

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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Stereotactic SBRT<br>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. | Radiation: SBRT<br>* hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival time without biochemical recurrence, | Phoenix definition of biochemical failure | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival time specific for prostate cancer, | the period of time from randomization until death from prostate cancer | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, SBRT, Ultrafractionation, CyberKnife