CyberKnife Radiosurgery for Locally Recurrent Prostate CA

Recurrent Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00851916
• Other study ID #: CK Recurrent Prostate SD
• Status: Recruiting
• Phase: Phase 2
• First received: February 25, 2009
• Last updated: July 18, 2017
• Start date: February 2009

Study information

• Verified date: July 2017
• Source: CyberKnife Centers of San Diego
• Contact: Carlyn Tripp
• Phone: 619-230-0400
• Email: ctripp[@]rmgmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Prostate Cancer

Intervention

Radiation:
• CyberKnife Radiosurgery
CyberKnife Radiosurgery

Locations

Country	Name	City	State
United States	CybeKnife Centers of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
CyberKnife Centers of San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish pattern of PSA decline		Post CyberKnife Radiosurgery - 5 year f/up
Secondary	Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer		Post CyberKnife Radiosurgery/5 yr. f/up