CyberKnife Radiosurgery for Localized Prostatic Carcinoma

July 18, 2017 updated by: Carlyn Tripp, CyberKnife Centers of San Diego

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

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

258

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92024
        • Recruiting
        • CyberKnife Centers of San Diego
        • Contact:
        • Principal Investigator:
          • Donald B Fuller, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CyberKnife Radiosurgery
Radiation: CyberKnife Radiosurgery
High Dose 3800 cGy/4 fractions
Radiation: CyberKnife Radiosurgery
Moderate Dose 3400 cGy/5 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CyberKnife Centers of San Diego

Investigators

  • Principal Investigator: Donald B Fuller, M.D., CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtual HDR CK Radiosurgery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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