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Evaluation of Daily CT Scans Using CT on Rails for Localization in the Treatment of Prostate Cancer


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Evaluation of Daily CT Scans Using CT on Rails for Localization in the Treatment of Prostate Cancer


OBJECTIVES:

Primary

- Validate the software for CT-on-rails™ by comparing prostate target localization via
daily ultrasound vs computed tomography (CT) in patients undergoing radiotherapy for
prostate cancer.

Secondary

- Determine the potential benefit of using fiducials in the prostate of patients
undergoing daily CT scans and/or ultrasounds for localization.

- Determine the intra- and inter-radiation treatment setup and target position
uncertainties, in terms of isocenter coordinates in space, using both the ultrasound
and CT scans compared to the coordinates of the isocenter determined at simulation, in
these patients.

OUTLINE: This is a pilot study.

- Phase I: Patients undergo computed tomography (CT) using CT-on-rails™ twice weekly.
Patients undergo BAT™ ultrasound daily for prostate localization. Patients undergo
concurrent daily radiotherapy off study after imaging. After radiotherapy treatment is
complete, patients continue to undergo scanning using CT-on-rails™ twice weekly.

- Phase II: Patients undergo local anesthesia and surgical insertion of gold fiducial
markers into the prostate. After 1 week, patients undergo a daily CT scan using
CT-on-rails™ and bi-weekly BAT™ ultrasound. Patients undergo daily radiotherapy off
study after imaging. After radiotherapy treatment is complete, patients continue to
undergo scanning using CT-on-rails™ twice weekly.

PROJECTED ACCRUAL: A total of 40 patients (20 per study phase) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of definitive prostate cancer

- Radiotherapy planned as treatment

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Validity of CT-on-rails software

Safety Issue:

No

Principal Investigator

Steven Feigenberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000365453

NCT ID:

NCT00084526

Start Date:

November 2003

Completion Date:

February 2007

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497