Cancer of the Prostate, Prostate Cancer, Prostate Neoplasm
Conditions
Keywords
Prostate cancer, CyberKnife, Stereotactic, Radiation
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.
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.
Interventions
RADIATIONCyberKnife Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Sponsors
Community Cancer Center, Normal, Illinois
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed