N/A
N=45
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
Prostate Cancer · Adenocarcinoma of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT02225925 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Procedure Time — 30 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brachytherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Time |
30 | — |
| SECONDARY Seed Reconstruction From Intra-operative Fluoroscopy |
45 | — |
| SECONDARY Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction |
— | — |
| SECONDARY Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater |
44 | — |
| SECONDARY Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry |
8 | — |
| SECONDARY Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema |
— | — |
| SECONDARY Quality of Life (QoL) Assessments |
— | — |
| SECONDARY Prostate Specific Antigen (PSA) Outcomes |
45 | — |
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 refine technical methods of using the system, as well as confirm its performance and accuracy.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02225925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.