A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Prostate Cancer Clinical Trial

Official title:

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02225262
• Other study ID #: CK Prostate-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Community Cancer Center, Normal, Illinois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Radiation:
• CyberKnife Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

Locations

Country	Name	City	State
United States	Community Cancer Center	Normal	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Community Cancer Center, Normal, Illinois

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5-10 years
Secondary	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.	5-10 years