Suspended

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

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What is being tested

CyberKnife Radiosurgery

Radiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2009
See protocol details

Summary

Principal SponsorCyberKnife Centers of San Diego
Study ContactCarlyn Tripp
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleVIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
NCT00851916
Principal SponsorCyberKnife Centers of San Diego
Study ContactCarlyn Tripp
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate
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.
Show More Criteria
9 exclusion criteria prevent from participating
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).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

CybeKnife Centers of San Diego

San Diego, United StatesOpen CybeKnife Centers of San Diego in Google Maps
SuspendedOne Study Center