A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Not Applicable

• Conditions: Prostate Cancer; Prostate Neoplasm; Cancer of the Prostate
• Interventions: Radiation: CyberKnife Radiosurgery

• Registration Number: NCT02225262
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24
• Primary Completion: 2020-01
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyberKnife Radiosurgery	CyberKnife Radiosurgery	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Community Cancer Center; 🇺🇸 Normal, Illinois, United States