A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

July 23, 2019 updated by: Community Cancer Center, Normal, Illinois

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Normal, Illinois, United States, 61761
        • Community Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male Age ≥ 21
  • Histologically proven prostate adenocarcinoma
  • Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
  • PSA ≤ 20 ng/ml
  • Prostate volume ≤ 100 cc

Patients belonging in one of the following risk groups:

  • Low:

    • CS T1b-T2a and Gleason 2-6 and PSA ≤ 10

  • Intermediate:

    • CS T2b and Gleason 2-6 and PSA ≤ 10, OR
    • CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml

Exclusion Criteria:

  • Any histology other than adenocarcinoma
  • Age < 21
  • KPS <= 40 <70
  • ECOG Performance Status ≥ 2
  • Patient weight >350 lbs. (table limitation)
  • Prior XRT to prostate or lower pelvis
  • Prior surgery or cryotherapy to prostate
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
  • Chemotherapy for a malignancy in the last 5 years
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
  • Hormone ablation for 2 months prior to enrollment, or during treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CyberKnife Radiosurgery
Radiation: CyberKnife Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Names:
  • CyberKnife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: 5-10 years
  • To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival [bDFS], Phoenix and ASTRO definitions, at 5 and 10 years).
  • To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.
5-10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5-10 years
To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.
5-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community Cancer Center, Normal, Illinois

Investigators

  • Principal Investigator: Shermian Woodhouse, MD, Community Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (ESTIMATE)

August 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK Prostate-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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