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Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT


N/A
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT


Inclusion Criteria:



- Men aged 40 - 80 years old

- Biopsy proven intermediate/high risk clinically localized prostate cancer, as
determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA >
10. Pathology will be confirmed by at least two reviews

- Patients opting for EBRT (external beam radiation therapy, standard of care) without
hormonal ablation

- Ability to undergo serial TRUS procedures

- Ability to give informed consent

Exclusion Criteria:

- Subject has known hypersensitivity to octafluoropropane.

- Evidence of distant metastatic disease on staging evaluation

- Previous treatment for prostate cancer, including any form of androgen ablation

- Previous procedures involving the anus or rectum, making serial TRUS difficult or
dangerous

- Expected life expectancy less than 10 years

- Baseline testosterone < 200 ng/dL

- Subject with cardiac shunts and elevated pulmonary hypertension

- Subject has worsening or clinically unstable congestive heart failure.

- Subject has acute myocardial infarction or acute coronary syndrome.

- Subject has ventricular arrhythmias or is high risk for arrhythmias.

- Subject has respiratory failure, severe emphysema or pulmonary emboli.

- Subject has a history of cardiac shunt or pulmonary hypertension.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To demonstrate measurable decrease in prostate vascularity during and/or after radiation treatment

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Edouard J Trabulsi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Food and Drug Administration

Study ID:

27012

NCT ID:

NCT00635167

Start Date:

January 2008

Completion Date:

June 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • prostatic vascularity
  • External Beam Radiation treatment
  • Contrast Enhanced transrectal Ultrasound
  • Prostatic Neoplasms

Name

Location

Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541