Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
Completed · Not applicable
Conditions studied: Prostate Cancer, Adenocarcinoma of the Prostate
In brief
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 refine technical methods of using the system, as well as confirm its performance and accuracy.
Key facts
- Study ID
- NCT02225925
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 45
- Starts
- 2014-10-01
- Expected to finish
- 2023-02-28
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The SKCCC at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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