Status:
UNKNOWN
CyberKnife Radiosurgery for Locally Recurrent Prostate CA
Lead Sponsor:
CyberKnife Centers of San Diego
Conditions:
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00851916
Start Date
February 1 2009
Last Update
July 21 2017
Active Locations (1)
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1
CybeKnife Centers of San Diego
San Diego, California, United States, 92024