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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: SBRT

• Registration Number: NCT03225235
• Lead Sponsor: The Greater Poland Cancer Centre

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.

Study Timeline

• Study Start: 2013-08-26
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-12
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Stereotactic SBRT	SBRT	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.

Primary Outcome Measures

Name	Time	Method
survival time without biochemical recurrence,	5 years	Phoenix definition of biochemical failure

Secondary Outcome Measures

Name	Time	Method
survival time specific for prostate cancer,	5 years	the period of time from randomization until death from prostate cancer

Trial Locations

Locations (1)

Greater Poland Cancer Centre; 🇵🇱 Poznan, Wielkopolska, Poland