CyberKnife Radiosurgery for Locally Recurrent Prostate CA

NCT ID: NCT00851916

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

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.

Conditions

Recurrent Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CyberKnife Radiosurgery

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

Group Type: OTHER

CyberKnife Radiosurgery

Intervention Type: RADIATION

CyberKnife Radiosurgery

Interventions

CyberKnife Radiosurgery

CyberKnife Radiosurgery

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CyberKnife Centers of San Diego

OTHER

Sponsor Role: lead

Responsible Party

Carlyn Tripp

Donald Fuller, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald B Fuller, M.D.

Role: PRINCIPAL_INVESTIGATOR

CyberKnife Centers of San Diego

Locations

CybeKnife Centers of San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carlyn Tripp

Role: CONTACT

ctripp@rmgmed.com

619-230-0400 ext. 224

Other Identifiers

CK Recurrent Prostate SD

Identifier Type: -

Identifier Source: org_study_id