Recruiting

Fiducials

Sponsor:

John Chang, MD

Code:

NCT01478412

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Polymer based fiducial placement

Study Details

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

Study ID

NCT01478412

Start date

Dec, 2011

Status verified date

Dec, 2011

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Males with prostate adenocarcinoma

English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.

Interventions

Polymer based fiducial placement

Fiducial marker placement with rectal ultrasound imaging.

Primary outcome measure

  • Ultrasound versus MRI image fusion for daily prostate positioning [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Lori A Abruscato, BS

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

Locations

ProCure Proton Therapy Center

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Lori A Abruscato, BS

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

Principal Investigator:

John Chang, MD

More Information

Sponsor

John Chang, MD

Last update posted

Dec 7, 2011

Last verified

Dec, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by John Chang, MD on 2011-12-07.