search
Back to results

A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Primary Purpose

Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Radiosurgery
Sponsored by
Community Cancer Center, Normal, Illinois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, CyberKnife, Stereotactic, Radiation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Community Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyberKnife Radiosurgery

Arm Description

Outcomes

Primary Outcome Measures

Local control rate
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

Overall survival
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.

Full Information

First Posted
August 22, 2014
Last Updated
July 23, 2019
Sponsor
Community Cancer Center, Normal, Illinois
search

1. Study Identification

Unique Protocol Identification Number
NCT02225262
Brief Title
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
Official Title
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Community Cancer Center, Normal, Illinois

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm
Keywords
Prostate cancer, CyberKnife, Stereotactic, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CyberKnife Radiosurgery
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Radiosurgery
Other Intervention Name(s)
CyberKnife
Intervention Description
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Primary Outcome Measure Information:
Title
Local control rate
Description
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.
Time Frame
5-10 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
5-10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shermian Woodhouse, MD
Organizational Affiliation
Community Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

We'll reach out to this number within 24 hrs