Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Procedure Time
Study Overview
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 refine technical methods of using the system, as well as confirm its performance and accuracy.
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 while limiting the doses to the surrounding normal tissue (i.e., bowel and bladder). It is established that outcomes after treatment with brachytherapy are related to the technical quality of source placement within the gland. Accurate placement of the radioactive sources with achievement of optimum dose distributions within the prostate is key to the success of brachytherapy with regard to both killing tumor as well as minimizing toxicity.
Due to factors such as deformations of the prostate during needle insertion, needle deviation from intended path during insertion, prostatic edema from needle trauma, and relaxation of tissues as well as source migration after needle removal, the actual source positions upon completion of the procedure may fail to accurately match their intended placement, resulting in variations from the idealized dosimetric plan.
One way to overcome this complex problem is to have the capability of visualizing the sources once they are in the prostate and then continuously updating the dosimetric plan in real time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are quantitatively integrated to allow for real-time visualization of source positions intraoperatively. A prior Phase I study performed by this group evaluated a prototype version of this mechanism, resulting in the successful treatment of 6 patients with true intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was excellent, and the intraoperative doses predicted by the system more accurate than that predicted by the current standard method (ultrasound-based dosimetry).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dynamic dosimetry brachytherapy
Cohort treated with dynamic dosimetry brachytherapy
Intervention: Brachytherapy (Radiation)
Outcomes
Primary Outcomes
Procedure Time
Time Frame: at time of implantation procedure
Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure
Secondary Outcomes
- Seed Reconstruction From Intra-operative Fluoroscopy(up to 30 days post-treatment)
- Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater(30 days post-treatment)
- Prostate Specific Antigen (PSA) Outcomes(up to 5 years)
- Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction(30 days post-treatment)
- Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry(Treatment - 30 days)
- Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema(Treatment - 30 days)
- Quality of Life (QoL) Assessments(baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5)