CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Accuray

Status

Completed

Conditions

Prostate Neoplasms

Prostatic Neoplasms

Prostatic Cancer

Prostate Cancer

Cancer of the Prostate

Treatments

Radiation: CyberKnife Stereotactic Radiosurgery - Low Risk

Radiation: CyberKnife Stereotactic Radiosurgery - Intermediate Risk

Study type

Interventional

Funder types

Industry

Identifiers

NCT00643617

ACCP002.2

Details and patient eligibility

About

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

Full description

In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues.

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Enrollment

307 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be at least 18 years of age
Histologically proven prostate adenocarcinoma
Biopsy within 1 year of date of registration
Clinical Stage (CS) T1b-T2b, N0, M0
Patients belonging to one of the following risk categories:
Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) < or = 10 ng/ml
Intermediate Risk: CS T2b, Gleason Score 2-6, PSA < or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA < or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA < or = 10 ng/ml
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion criteria

Clinical Stage T2c or greater
Prior prostatectomy or cryotherapy of the prostate
Prior radiotherapy of the prostate or lower pelvis
Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
Hormone ablation for two months prior to enrollment or during treatment