Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Brachytherapy

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The SKCCC at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic dosimetry brachytherapy; Cohort treated with dynamic dosimetry brachytherapy	Radiation: Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seed Reconstruction From Intra-operative Fluoroscopy	Number of patients with all seeds reconstructed from fluoroscopy	up to 30 days post-treatment
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
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
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
Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema		Treatment - 30 days
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
Prostate Specific Antigen (PSA) Outcomes	PSA biochemical failure-free survival at last follow-up visit	up to 5 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Danny Song, M.D., The SKCCC at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: brachytherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: J13164; NA_00091766 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No