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A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02225262
Recruitment Status : Unknown
Verified July 2019 by Community Cancer Center, Normal, Illinois.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2014
Last Update Posted : July 24, 2019
Information provided by (Responsible Party):
Community Cancer Center, Normal, Illinois

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Cancer of the Prostate Prostate Neoplasm Radiation: CyberKnife Radiosurgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
Study Start Date : January 2008
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: CyberKnife Radiosurgery Radiation: CyberKnife Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Name: CyberKnife

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02225262

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United States, Illinois
Community Cancer Center
Normal, Illinois, United States, 61761
Sponsors and Collaborators
Community Cancer Center, Normal, Illinois
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Principal Investigator: Shermian Woodhouse, MD Community Cancer Center
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Responsible Party: Community Cancer Center, Normal, Illinois Identifier: NCT02225262    
Other Study ID Numbers: CK Prostate-01
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Community Cancer Center, Normal, Illinois:
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases