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Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into
a tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate
brachytherapy is a particularly elegant brachytherapy dose sculpting method that is
effectively used in the curative treatment of prostate cancer; however, it requires hospital
admission and many temporarily implanted transperineal catheters to deliver the radiation
source to the target volume, resulting in significant patient discomfort. CyberKnife
delivers a form of radiation treatment that is so precise, it appears capable of
reconstructing HDR prostate radiation dose sculpting, without the hospital admission and
without the catheters. The CyberKnife device is also used for classic radiosurgery, with
accuracy comparable to the Gamma Knife, but unlike the Gamma Knife, has the capability to
target lesions anywhere in the body with similar accuracy. The aim of this study is to
compare CyberKnife morbidity and efficacy with that of HDR and other local treatment methods
such a permanent seed prostate brachytherapy in the treatment of prostate cancer.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b
(AJCC 6th Edition, see Appendix II), NX/N0, M0.

- Karnofsky performance status > 80.

- Patient must be ≥ 18 years of age.

- Gleason Sum < or = 7

- Prostate-specific antigen < or = 20 ng/ml

- Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

- Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).

- Gleason Score > 7.

- PSA > 20 ng/ml.

- Lymph node involvement (N1).

- Evidence of distant metastases (M1).

- Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic
surgical clips or other metallic foreign bodies.

- History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three
months prior to treatment).

- Previous or concurrent cancers other than basal, in situ, or squamous cell skin
cancers unless disease-free for ≥ 5 years.

- Major medical or psychiatric illness, which in the investigator's opinion, would
prevent completion of treatment and would interfere with follow-up.

- Metallic Hip prosthesis.

- History of inflammatory bowel disease

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Donald B Fuller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners


United States: Institutional Review Board

Study ID:

Virtual HDR CK Radiosurgery



Start Date:

March 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Cancer
  • Prostatic Neoplasms
  • Prostate Neoplasms
  • Cancer of the Prostate
  • Carcinoma
  • Prostatic Neoplasms



CyberKnife Centers of San DiegoSan Diego, California  92101