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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: SBRT

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piotr Milecki, PhD., MD; Phone Number: +48618850878; Email: piotr.milecki@wco.pl
• Study Contact Backup: Name: Sylwia Krąkowska, MD; Phone Number: +48 61 885 08 78; Email: sylwia.krakowska@wco.pl

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-866
      • Recruiting
      • Greater Poland Cancer Centre
      • Contact: Piotr Milecki, MD PhD; Phone Number: +48 61 885 08 78; Email: piotr.milecki@wco.pl
      • Contact: Sylwia Krąkowska, MA; Phone Number: +48 61 885 08 78; Email: sylwia.krakowska@wco.pl
      • Principal Investigator: Piotr Milecki, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL-EORTC quality of life	For QoL the EORTC questionnaire (C30 with PR25) is used.	5 years

Collaborators and Investigators

• Sponsor: The Greater Poland Cancer Centre
• Investigators: Principal Investigator: Piotr Milecki, PhD., MD, Greater Poland Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2013
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer, SBRT, Ultrafractionation, CyberKnife
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CYBERPROST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No