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

The Greater Poland Cancer Centre

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03225235

CYBERPROST

Details and patient eligibility

About

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.

Full description

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

Enrollment: 600 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Hypofractionated Stereotactic SBRT

Experimental group

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.

Treatment:

Radiation: SBRT