Status:
COMPLETED
Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
United States Department of Defense
Conditions:
Locally Confined Adenocarcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This will be a phase I study. This phase I study is not a standard drug dose escalation study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device. However for purposes o...
Detailed Description
This will be a prospective Phase I study. Subject Identification: Patient confidentiality will be maintained in accordance with Health Information Portability and Accountability Act (HIPAA) guideline...
Eligibility Criteria
Inclusion
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- PSA of less than 10 ngmL
- Combined Gleason score 6 or less, with no individual Gleason score of 4 or 5
- The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer
- Karnofsky Performance Status greater than 70
- Prostate volume by TRUS less than 50 cc
- International Prostate symptom score must be 18 or less
- Signed study-specific consent form prior to registration
Exclusion
- Clinical or Pathological Lymph node involvement,
- Evidence of distant metastases
- Radical surgery for carcinoma of the prostate
- Chemotherapy or pelvic radiation therapy
- Previous transurethral resection of the prostate
- Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease free for at least 5 years.
- Significant obstructive symptoms
- Major medical or psychiatric illness which, in the investigator's opinion, Hip prosthesis
- Anatomic or medical condition (such as prior abdominal perineal resection or anal stricture) which would preclude the use of TRUS Implanted device or apparatus which might obstruct visibility of the implanted sources on fluoroscopy
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00426959
Start Date
February 1 2005
End Date
April 1 2010
Last Update
November 14 2012
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University
Baltimore, Maryland, United States, 21231