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CyberKnife Radiosurgery for Locally Recurrent Prostate CA

This study is currently recruiting participants.
Verified July 2017 by Carlyn Tripp, CyberKnife Centers of San Diego
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851916
First Posted: February 26, 2009
Last Update Posted: July 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Carlyn Tripp, CyberKnife Centers of San Diego
  Purpose

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 Intervention Phase
Recurrent Prostate Cancer Radiation: CyberKnife Radiosurgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY

Resource links provided by NLM:


Further study details as provided by Carlyn Tripp, CyberKnife Centers of San Diego:

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

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

Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00851916


Contacts
Contact: Carlyn Tripp 619-230-0400 ext 224 ctripp@rmgmed.com

Locations
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
Investigators
Principal Investigator: Donald B Fuller, M.D. CyberKnife Centers of San Diego
  More Information

Responsible Party: Carlyn Tripp, Donald Fuller, M.D., CyberKnife Centers of San Diego
ClinicalTrials.gov Identifier: NCT00851916     History of Changes
Other Study ID Numbers: CK Recurrent Prostate SD
First Submitted: February 25, 2009
First Posted: February 26, 2009
Last Update Posted: July 21, 2017
Last Verified: July 2017