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

NCT ID: NCT03225235

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-26
• Study Completion Date: 2025-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

Interventions

SBRT

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Greater Poland Cancer Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Milecki, PhD., MD

Role: PRINCIPAL_INVESTIGATOR

Greater Poland Cancer Centre

Locations

Greater Poland Cancer Centre

Poznan, Wielkopolska, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Piotr Milecki, PhD., MD

Role: CONTACT

piotr.milecki@wco.pl

+48618850878

Sylwia Krąkowska, MD

Role: CONTACT

sylwia.krakowska@wco.pl

+48 61 885 08 78

Facility Contacts

Piotr Milecki, MD PhD

Role: primary

piotr.milecki@wco.pl

+48 61 885 08 78

Sylwia Krąkowska, MA

Role: backup

sylwia.krakowska@wco.pl

+48 61 885 08 78

Other Identifiers

CYBERPROST

Identifier Type: -

Identifier Source: org_study_id