Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225925
• Other study ID #: J13164
• Secondary ID: NA_00091766
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 28, 2023
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer

Intervention

Radiation:
• Brachytherapy

Locations

Country	Name	City	State
United States	The SKCCC at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Time	Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure	at time of implantation procedure
Secondary	Seed Reconstruction From Intra-operative Fluoroscopy	Number of patients with all seeds reconstructed from fluoroscopy	up to 30 days post-treatment
Secondary	Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction	Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)	30 days post-treatment
Secondary	Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater	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	30 days post-treatment
Secondary	Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry	Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry	Treatment - 30 days
Secondary	Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema		Treatment - 30 days
Secondary	Quality of Life (QoL) Assessments	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)	baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5
Secondary	Prostate Specific Antigen (PSA) Outcomes	PSA biochemical failure-free survival at last follow-up visit	up to 5 years