NCT00061347

Brief Summary

To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles. Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started May 2003

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2004

Completed
13.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2018

Completed
Last Updated

April 23, 2018

Status Verified

April 19, 2018

Enrollment Period

1 year

First QC Date

May 23, 2003

Last Update Submit

April 20, 2018

Conditions

Prostate CancerCancer

Keywords

Fiducial MarkerMRIProstate CancerRadiation

Outcome Measures

Primary Outcomes (2)

  • To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate

    1, 3, 6, 12, 18, 24, 36, 48, and 60 months

  • To determine the toxicity of MR-Guided fiducial marker placement

    1, 3, 6, 12, 18, 24, 36, 48, and 60 months

Secondary Outcomes (5)

  • To gain preliminary experience using intraprostatic fiducial markers for daily set-up assessment and adjustment of external radiation beam targeting.

    completion of study

  • To gain preliminary experience using intraprostatic fiducial markers for image fusion.

    completion of study

  • To measure the magnitude of marker migration during the course of radiotherapy.

    completion of study

  • To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.

    completion of study

  • To gather data on the feasibility, tolerability, and effectiveness of local anesthetic injection along the neurovascular bundle under MRI guidance.

    completion of study

Study Arms (1)

1

EXPERIMENTAL

Placement of fidicual markers under MRI guidance for localization of radiaiton treatment

Procedure: Fiducial marker placement

Interventions

Fiducial marker placementPROCEDURE

Placement of fidicual markers under MRI guidance for localization of radiaiton treatment

1

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii. doi: 10.1016/s0033-8389(05)70150-0.

    PMID: 10664667BACKGROUND

  • Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6. doi: 10.1002/(sici)1522-2586(199909)10:33.0.co;2-7.

    PMID: 10508285BACKGROUND

  • Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805. doi: 10.1148/radiology.198.3.8628874.

    PMID: 8628874BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kevin A Camphausen, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2003

First Posted

May 26, 2003

Study Start

May 23, 2003

Primary Completion

May 31, 2004

Study Completion

April 19, 2018

Last Updated

April 23, 2018

Record last verified: 2018-04-19

Locations

US(1)