Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound

Not Applicable

Completed

Conditions: Prostate Cancer
Adenocarcinoma of the Prostate

Interventions: Radiation: Brachytherapy

Registration Number: NCT02225925

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic dosimetry brachytherapy	Brachytherapy	Cohort treated with dynamic dosimetry brachytherapy

Primary Outcome Measures

Name	Time	Method
Procedure Time	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 Outcome Measures

Name	Time	Method
Seed Reconstruction From Intra-operative Fluoroscopy	up to 30 days post-treatment	Number of patients with all seeds reconstructed from fluoroscopy
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	Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater
Prostate Specific Antigen (PSA) Outcomes	up to 5 years	PSA biochemical failure-free survival at last follow-up visit
Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction	30 days post-treatment	Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)
Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry	Treatment - 30 days	Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry
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	Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)