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

NCT03225235 | Unknown

• 1 other identifier: CYBERPROST
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer, SBRT, Ultrafractionation, CyberKnife

Outcome Measures

Primary Outcomes (1)

• survival time without biochemical recurrence,

  Phoenix definition of biochemical failure

  5 years

Secondary Outcomes (1)

• survival time specific for prostate cancer,

  5 years

Other Outcomes (1)

• QoL-EORTC quality of life

  5 years

Study Arms (1)

Hypofractionated Stereotactic SBRT

EXPERIMENTAL

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

Interventions

SBRT RADIATION

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

Hypofractionated Stereotactic SBRT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Greater Poland Cancer Centre: lead

Study Sites (1)

Greater Poland Cancer Centre

Poznan, Wielkopolska, 61-866, Poland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Piotr Milecki, PhD., MD

  Greater Poland Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Milecki, PhD., MD

CONTACT

+48618850878; piotr.milecki@wco.pl

Sylwia Krąkowska, MD

CONTACT

+48 61 885 08 78; sylwia.krakowska@wco.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: July 21, 2017
• Study Start: August 26, 2013
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2025
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)