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

Prostate Cancer Clinical Trial

— CYBERPROST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225235
• Other study ID #: CYBERPROST
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2013
• Est. completion date: August 2025

Study information

• Verified date: February 2020
• Source: The Greater Poland Cancer Centre
• Contact: Piotr Milecki, PhD., MD
• Phone: +48618850878
• Email: piotr.milecki[@]wco.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Poland	Greater Poland Cancer Centre	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
The Greater Poland Cancer Centre

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QoL-EORTC quality of life	For QoL the EORTC questionnaire (C30 with PR25) is used.	5 years
Primary	survival time without biochemical recurrence,	Phoenix definition of biochemical failure	5 years
Secondary	survival time specific for prostate cancer,	the period of time from randomization until death from prostate cancer	5 years