Back to resultsProspective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer (CYBERPROST)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, SBRT, Ultrafractionation, CyberKnife
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.
Sites / Locations
- Greater Poland Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionated Stereotactic SBRT
Arm Description
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.
Outcomes
Primary Outcome Measures
survival time without biochemical recurrence,
Phoenix definition of biochemical failure
Secondary Outcome Measures
survival time specific for prostate cancer,
the period of time from randomization until death from prostate cancer
Full Information
NCT ID
NCT03225235
First Posted
May 19, 2017
Last Updated
February 4, 2020
Sponsor
The Greater Poland Cancer Centre
1. Study Identification
Unique Protocol Identification Number
NCT03225235
Brief Title
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
Acronym
CYBERPROST
Official Title
Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2013 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Greater Poland Cancer Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, SBRT, Ultrafractionation, CyberKnife
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated Stereotactic SBRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer
Primary Outcome Measure Information:
Title
survival time without biochemical recurrence,
Description
Phoenix definition of biochemical failure
Time Frame
5 years
Secondary Outcome Measure Information:
Title
survival time specific for prostate cancer,
Description
the period of time from randomization until death from prostate cancer
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
QoL-EORTC quality of life
Description
For QoL the EORTC questionnaire (C30 with PR25) is used.
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Milecki, PhD., MD
Phone
+48618850878
Email
piotr.milecki@wco.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Sylwia Krąkowska, MD
Phone
+48 61 885 08 78
Email
sylwia.krakowska@wco.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Milecki, PhD., MD
Organizational Affiliation
Greater Poland Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Poland Cancer Centre
City
Poznan
State/Province
Wielkopolska
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Milecki, MD PhD
Phone
+48 61 885 08 78
Email
piotr.milecki@wco.pl
First Name & Middle Initial & Last Name & Degree
Sylwia Krąkowska, MA
Phone
+48 61 885 08 78
Email
sylwia.krakowska@wco.pl
First Name & Middle Initial & Last Name & Degree
Piotr Milecki, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
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