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Trial record 2 of 91 for:    prostate cancer Poland

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

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ClinicalTrials.gov Identifier: NCT03225235
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: SBRT Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
Actual Study Start Date : August 26, 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Hypofractionated Stereotactic 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.
Radiation: SBRT
hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer




Primary Outcome Measures :
  1. survival time without biochemical recurrence, [ Time Frame: 5 years ]
    Phoenix definition of biochemical failure


Secondary Outcome Measures :
  1. survival time specific for prostate cancer, [ Time Frame: 5 years ]
    the period of time from randomization until death from prostate cancer


Other Outcome Measures:
  1. QoL-EORTC quality of life [ Time Frame: 5 years ]
    For QoL the EORTC questionnaire (C30 with PR25) is used.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225235


Contacts
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Contact: Piotr Milecki, PhD., MD +48618850878 piotr.milecki@wco.pl
Contact: Sylwia Krąkowska, MD +48 61 885 08 78 sylwia.krakowska@wco.pl

Locations
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Poland
Greater Poland Cancer Centre Recruiting
Poznan, Wielkopolska, Poland, 61-866
Contact: Piotr Milecki, MD PhD    +48 61 885 08 78    piotr.milecki@wco.pl   
Contact: Sylwia Krąkowska, MA    +48 61 885 08 78    sylwia.krakowska@wco.pl   
Principal Investigator: Piotr Milecki, MD PhD         
Sponsors and Collaborators
The Greater Poland Cancer Centre
Investigators
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Principal Investigator: Piotr Milecki, PhD., MD Greater Poland Cancer Centre

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Responsible Party: The Greater Poland Cancer Centre
ClinicalTrials.gov Identifier: NCT03225235     History of Changes
Other Study ID Numbers: CYBERPROST
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Greater Poland Cancer Centre:
Prostate cancer, SBRT, Ultrafractionation, CyberKnife
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases