CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer

Status unconfirmed · Not applicable

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays 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. The purpose of this evaluation is to see if this treatment will help patients with low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patients' quality of life over time.

Key facts

Study ID

NCT02070952

Run by

Riverside Community Hospital, California

People needed

167

Starts

2013-07-01

Expected to finish

2018-07-01

Last updated by the study team

2014-02-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven prostate adenocarcinoma
• Gleason score 2-7 (reviewed by reference lab)
• Biopsy within 6 months of date of registration
• Clinical stage (CS) T1a-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
• T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
• M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
• PSA less than or equal to 20 ng/ml
• Patients belonging in one of the following risk groups:
• Low: CS T1a-T2a and Gleason 2-6 and PSA less than or equal to 10, or
• Intermediate: CS T2b and Gleason 2-6 and PSA less than or equal to 10, or CS T1b-T2b, and Gleason 2-6 and PSA less than or equal to 20 ng/ml, or Gleason 7 and PSA less than or equal to 10 ng/ml
• Prostate volume less than or equal to 100 cc
• Determined using: volume = π/6 x length x height x width
• Measurement from CT or ultrasound less than or equal to 90 days prior to registration
• Eastern Cooperative Oncology Group (ECOG performance status 0-1
• No prior prostatectomy or cryotherapy of the prostate
• No prior radiotherapy to the prostate or lower pelvis
• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
• Completion of patient questionnaires.
• Consent signed.
• Intermediate risk patients may be treated with 4-6 months of hormonal therapy at the discretion of the treating physician.

Where it is running

• Riverside Community Hospital — Riverside, California, United States (enrolling)

Full record on ClinicalTrials.gov

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