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A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Sponsor
Community Cancer Center, Normal, Illinois (Other)
Overall Status
Unknown status
CT.gov ID
NCT02225262
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
155
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: CyberKnife Radiosurgery
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2008
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Local control rate [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Community Cancer Center Normal Illinois United States 61761

    Sponsors and Collaborators

    • Community Cancer Center, Normal, Illinois

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Community Cancer Center, Normal, Illinois
    ClinicalTrials.gov Identifier:
    NCT02225262
    Other Study ID Numbers:
    • CK Prostate-01
    First Posted:
    Aug 26, 2014
    Last Update Posted:
    Jul 24, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Community Cancer Center, Normal, Illinois
    Prostate cancer
    CyberKnife
    Stereotactic
    Radiation
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 24, 2019