Status:
WITHDRAWN
Gene Therapy for Prostate Cancer That Returns After Radiation Therapy
Lead Sponsor:
Simon Hall
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Prostatic Neoplasms
Neoplasm Recurrence, Local
Eligibility:
MALE
40-75 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to test a new treatment for prostate cancer. We have been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a virus which prod...
Detailed Description
Patients with radiorecurrent prostate cancer have few viable treatment options, both in terms of efficacy and morbidity. Local therapies fail even in highly selected patients due to locally advanced d...
Eligibility Criteria
Inclusion
- A local recurrence of prostate cancer (in or next to gland) following treatment by radiation therapy (either external beam or seed implantation)
- Rising PSA (Prostate Specific Antigen) on at least three occasions separated by two weeks
- Ultrasound guided biopsy to diagnose recurrent disease within the prostate
- No evidence of prostate cancer that has spread on bone scan or Computed Tomography (CT) scan
- No hormone therapy at time of enrollment to the research study
Exclusion
- Radical prostatectomy for treatment of prostate cancer
- Detectable spread of prostate cancer on bone or CT scan
- Immunosuppressive medication within two months of the study
- Acute infection (any bacterial, viral, fungal infection requiring specific therapy)
- HIV disease
- Other significant medical or psychiatric conditions which pose high risk for an investigational study
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00110526
Start Date
April 1 2005
End Date
April 1 2008
Last Update
October 24 2013
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