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CyberKnife Radiosurgery for Locally Recurrent Prostate CA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851916
Recruitment Status : Unknown
Verified July 2017 by Carlyn Tripp, CyberKnife Centers of San Diego.
Recruitment status was:  Recruiting
First Posted : February 26, 2009
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Carlyn Tripp, CyberKnife Centers of San Diego

Brief Summary:

The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.

This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Cancer Radiation: CyberKnife Radiosurgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2009
Estimated Primary Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
CyberKnife Radiosurgery
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
Radiation: CyberKnife Radiosurgery
CyberKnife Radiosurgery

Primary Outcome Measures :
  1. Establish pattern of PSA decline [ Time Frame: Post CyberKnife Radiosurgery - 5 year f/up ]

Secondary Outcome Measures :
  1. Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer [ Time Frame: Post CyberKnife Radiosurgery/5 yr. f/up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
  • Karnofsky performance status >80.
  • Greater than 5 year life expectancy
  • Greater than 2 years since the original course of radiotherapy.
  • Absence of distant metastases by radiologic or pathologic assessment.
  • Absence of lymph node involvement by radiologic or pathologic assessment.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Stage T4 disease (AJCC 6th Edition, see Appendix II).
  • Less than 2 years since the original course of radiotherapy.
  • Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate
  • 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.
  • History of inflammatory bowel disease
  • Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851916

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Contact: Carlyn Tripp 619-230-0400 ext 224

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United States, California
CybeKnife Centers of San Diego Recruiting
San Diego, California, United States, 92024
Principal Investigator: Donald B. Fuller, M.D.         
Sponsors and Collaborators
CyberKnife Centers of San Diego
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Principal Investigator: Donald B Fuller, M.D. CyberKnife Centers of San Diego

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Responsible Party: Carlyn Tripp, Donald Fuller, M.D., CyberKnife Centers of San Diego Identifier: NCT00851916    
Other Study ID Numbers: CK Recurrent Prostate SD
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases