A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Status unconfirmed · Not applicable

Conditions studied: Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm

In brief

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.

Key facts

Study ID

NCT02225262

Run by

Community Cancer Center, Normal, Illinois

People needed

100

Starts

2008-01-01

Expected to finish

2020-12-01

Last updated by the study team

2019-07-24

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Community Cancer Center — Normal, Illinois, United States

Full record on ClinicalTrials.gov

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