Status:
COMPLETED
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Prostate Cancer
Adenocarcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and ref...
Detailed Description
The use of brachytherapy or implantation of radioactive sources into the prostate for adenocarcinoma has advantages over external beam radiation in that a very high dose can be delivered to the tumor ...
Eligibility Criteria
Inclusion
- Histologically confirmed, localized adenocarcinoma of the prostate
- Clinical stages T1b - T3a
- The patient has decided to undergo brachytherapy (or brachytherapy plus external beam radiation) as a treatment modality for his prostate cancer
- Karnofsky Performance Status \> 60
- Prostate volume by transrectal ultrasound (TRUS) \< 55 cc
- International Prostate symptom score (IPSS) 20 or less
- Ability to have Magnetic resonance imaging as part of post-implant assessment
- Signed study-specific consent form prior to registration
Exclusion
- Stage T3b or greater disease.
- Prior history of pelvic radiation therapy
- Significant obstructive symptoms (IPSS greater than 20)
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
- Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
- Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02225925
Start Date
October 1 2014
End Date
February 28 2023
Last Update
March 13 2023
Active Locations (1)
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1
The SKCCC at Johns Hopkins
Baltimore, Maryland, United States, 21287