An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer (Clarity)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ProCure Proton Therapy Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Chang, MD, ProCure Proton Therapy Center
ClinicalTrials.gov Identifier:
NCT01478412
First received: November 21, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.


Condition Intervention
Prostate Adenocarcinoma
Other: Polymer based fiducial placement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by ProCure Proton Therapy Center:

Primary Outcome Measures:
  • Ultrasound versus MRI image fusion for daily prostate positioning [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Polymer based marker visualization [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To determine if polymer based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers


Estimated Enrollment: 20
Study Start Date: December 2011
Groups/Cohorts Assigned Interventions
Males with prostate adenocarcinoma
English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.
Other: Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.

Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Members of all races and ethnic groups are eligible for this trial. Since this is a prostate study, only males will be enrolled.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478412

Contacts
Contact: Lori A Abruscato, BS 630-821-6397 lori.abruscato@chi.procure.com

Locations
United States, Illinois
ProCure Proton Therapy Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Lori A Abruscato, BS    630-821-6397    lori.abruscato@chi.procure.com   
Principal Investigator: John Chang, MD         
Sponsors and Collaborators
John Chang, MD
Investigators
Principal Investigator: John Chang, MD ProCure Proton Therapy Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Chang, MD, ProCure Proton Therapy Center
ClinicalTrials.gov Identifier: NCT01478412     History of Changes
Other Study ID Numbers: CHI-001
Study First Received: November 21, 2011
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by ProCure Proton Therapy Center:
Prostate cancer
Low risk
Intermediate risk
T1
T2a
T2b
Gleason 6
Gleason 7
PSA 10
PSA 20

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014