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Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study

Phase 1
18 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study

Effective image-guided prostate therapies require excellent visualization of the prostate
and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby
neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for
image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and
the potential to yield spectral/biological tumor mapping. Despite the potential for
MRI-guided prostate therapies, there are currently no techniques that allow for precise
trans-rectal intraprostatic needle placement in patients.

In this pilot study we seek to validate the accuracy and tolerability of a new system and
technique that allows for accurate placement of needles within the prostate based upon MR
images. The method is very similar to transrectal ultrasound guided biopsy of the prostate,
except that it is applicable within a closed high-field MRI scanner. Four gold fiducial
markers will be placed within the prostate under needle guidance in a series of patients
with localized prostate cancer before external beam radiotherapy. Fifteen patients will be
enrolled onto this study with sample size determined to obtain reasonably precise estimates
of mean placement accuracy. The accrual period is expected to be less than a year.

While placement of the fiducial markers has no direct therapeutic benefit for the patient,
intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in
assessing daily setup errors and off-line organ motion during external beam radiation
therapy for prostate cancer. Therefore, a secondary objective is to gain experience using
these intraprostatic fiducial markers for daily assessment and adjustment of external
radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and
results in better target delineation for treatment planning. In this way, prostate cancer
patients who are receiving external-beam radiation therapy may benefit from participation.

Inclusion Criteria


- Pathologically confirmed adenocarcinoma of the prostate gland.

- Age greater than or equal to 18 years.

- ECOG performance status of 0 or 1.

- Informed consent: All patients must sign a document of informed consent indicating
their understanding of the investigational nature and risks of the study before any
protocol related studies are performed (this does not include routine laboratory
tests or imaging studies required to establish eligibility).


Patients with contraindication to transrectal needle placement:

- Bleeding disorder;

- PT/PTT greater than 1.5.times the upper limit of normal;

- Platelets less than 50K;

- Artificial heart valve.

Patients with contraindications to MRI:

- Patients weighing greater than 136 kg (weight limit for scanner table);

- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implanted
electronic devices.

- Patients with chronic inflammatory bowel disease.

- Patients with distant metastatic disease.

- Patients with a prior history of pelvic or prostate radiotherapy.

- Cognitively impaired patients who cannot give informed consent.

- Other medical conditions deemed by the PI or associates to make the patient
ineligible for protocol investigations, procedures, and high-dose external beam

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kevin A Camphausen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

April 2011

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Radiation Therapy
  • MRI
  • Fiducial Marker
  • Neoplasms
  • Prostatic Neoplasms



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