The SKCCC at Johns Hopkins
Baltimore, Maryland, 21287, United States
NCT Number: NCT02225925
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: up to 30 days post-treatment
Number of patients with all seeds reconstructed from fluoroscopy
Time frame: 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)
Time frame: 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
Time frame: Treatment - 30 days
Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry
Time frame: Treatment - 30 days
Time frame: 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)
Time frame: up to 5 years
PSA biochemical failure-free survival at last follow-up visit
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound
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