Status:
UNKNOWN
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
Lead Sponsor:
Community Cancer Center, Normal, Illinois
Conditions:
Prostate Cancer
Cancer of the Prostate
Eligibility:
MALE
21+ years
Phase:
NA
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 radioth...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02225262
Start Date
January 1 2008
End Date
December 1 2020
Last Update
July 24 2019
Active Locations (1)
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1
Community Cancer Center
Normal, Illinois, United States, 61761