NCT02225925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 25, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

April 8, 2014

Results QC Date

October 14, 2019

Last Update Submit

March 9, 2023

Conditions

Prostate CancerAdenocarcinoma of the Prostate

Keywords

brachytherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Seed Reconstruction From Intra-operative Fluoroscopy

    up to 30 days post-treatment

  • Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction

    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

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Dynamic dosimetry brachytherapy

EXPERIMENTAL

Cohort treated with dynamic dosimetry brachytherapy

Radiation: Brachytherapy

Interventions

BrachytherapyRADIATION
Dynamic dosimetry brachytherapy

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Results Point of Contact

Title
Daniel Song
Organization
Johns Hopkins University
dsong2@jhmi.edu
410-502-5875

Study Officials

  • Danny Song, M.D.

    The SKCCC at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

August 26, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

February 28, 2023

Last Updated

March 13, 2023

Results First Posted

February 25, 2020

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)