CyberKnife Radiosurgery for Locally Recurrent Prostate CA

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

VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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
        • CybeKnife Centers of San Diego
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Establish pattern of PSA decline
Time Frame: Post CyberKnife Radiosurgery - 5 year f/up
Post CyberKnife Radiosurgery - 5 year f/up

Secondary Outcome Measures

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

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

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

February 1, 2009

Primary Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK Recurrent Prostate SD

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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