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A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Adenocarcinoma

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Trial Information

A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer


The investigators will also be assessing the following:

1. Whether polymer-based markers can be adequately visualized on daily stereoscopic
imaging compared to gold seed markers.

2. Whether polymer-based markers are visible on ultrasound imaging.

3. To determine if the polymer-based marker produces fewer artifacts on treatment planning
CT scans than gold markers.


Inclusion Criteria:



- Histologically confirmed prostate adenocarcinoma

- diagnosis of low risk or intermediate risk prostate cancer

- approved for proton therapy treatment at CDH ProCure Proton Therapy Center

- prescribed and consented for the placement of fiducial markers into the prostate as
part of the standard treatment procedure

- capable of receiving an MRI of the pelvis region for prostate localization

- the prostate gland of eligible patients must be capable of imaging from an anterior
trans-abdominal ultrasound as determined by the treating investigator

- must be fluent in the English language; must be able to provide written study consent

Exclusion Criteria:

- Evidence of a large TURP defect per investigator discretion

- previous prostate cancer surgery including prostatectomy, hyperthermia and
cryosurgery

- previous pelvic radiation for prostate cancer

- current grade 2 or above incontinence

- history of orthopedic procedures in the area of the treatment, specifically no prior
hip replacement or procedure in which metallic or high density material remains which
would be within stereoscopic kilovoltage imaging area

- prior permanent placement of any metallic or high density material within the
prostate

- known allergy to ultrasonic gel

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Ultrasound versus MRI image fusion for daily prostate positioning

Outcome Description:

Determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion method, and if alighment crrection vectors obtained from ultransound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

John Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ProCure Proton Therapy Center

Authority:

United States: Institutional Review Board

Study ID:

CHI-001

NCT ID:

NCT01478412

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Prostate Adenocarcinoma
  • Prostate cancer
  • Low risk
  • Intermediate risk
  • T1
  • T2a
  • T2b
  • Gleason 6
  • Gleason 7
  • PSA 10
  • PSA 20
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

ProCure Proton Therapy CenterWarrenville, Illinois  60555