Clinical Trial Details

< Previous Trial     Next Trial >
Study ID 06-147
Investigator
Ronald Ennis, MD,   St. Luke's-Roosevelt Hospital Center
Title Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
Conditions Clinical Stage T2b or Less of Prostate Cancer
Prostate Brachytherapy
Transrectal Prostate Ultrasound Treatment Planning
Interventions Other: An ultrasound-based technique to identify prostate cancer
Other: pre-implant transrectal ultrasound images and planning
Other: ultrasound-based cancer-specific images
Phase Phase 1/Phase 2
Purpose In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
  • PSA ≤ 10 ng/ml
  • Gleason sum on biopsy ≤ 6
  • Prostate volume ≤ 50 cc
  • Willing to continue follow-up for at least two years.
Exclusion Criteria:
  • No prior hormone therapy
  • No prior radiotherapy
  • No history of collagen vascular disease
  • No history of inflammatory bowel disease
Study Location
St.Luke's-Roosevelt Hospital Center
New York, New York, 10019
Contact N/A

Information objtained from ClinicalTrials.gov, on 8/1/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227642


Back to Search Results