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

NCT01478412 | Unknown

• 1 other identifier: CHI-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Keywords

Prostate cancer; Low risk; Intermediate risk; T1; T2a; T2b; Gleason 6; Gleason 7; PSA 10; PSA 20

Outcome Measures

Primary Outcomes (1)

• Ultrasound versus MRI image fusion for daily prostate positioning

  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.

  4 months

Secondary Outcomes (1)

• Polymer based marker visualization

  4 months

Study Arms (1)

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

Interventions

Polymer based fiducial placement OTHER

Fiducial marker placement with rectal ultrasound imaging.

Males with prostate adenocarcinoma

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Chang, MD: lead

Study Sites (1)

ProCure Proton Therapy Center

Warrenville, Illinois, 60555, United States

RECRUITING

Related Links

• ProCure Proton Therapy Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Chang, MD

  ProCure Proton Therapy Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Abruscato, BS

CONTACT

630-821-6397; lori.abruscato@chi.procure.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: John Chang, MD

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: December 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

US (1)