MRI in Finding Cancer in Patients With Confirmed or Suspected Prostate Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085514

Purpose

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to find cancer and to determine the extent of disease. MRI may also make it easier for doctors to collect tissue samples from the tumor and plan more effective treatment.

PURPOSE: This clinical trial is studying how well MRI works in finding cancer and determining the extent of disease in patients with confirmed or suspected prostate cancer.

Condition	Intervention
Prostate Cancer	Drug: gadopentetate dimeglumine Procedure: endoscopic biopsy Procedure: magnetic resonance imaging

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer

Drug Information available for: Gadolinium dtpa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	A Prospective Histopathologic Study of Dynamic Contrast Enhanced MRI for Prostate Cancer Delineation and Characterization With the APT-MRI System

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	80
Study Start Date:	May 2004

Detailed Description:

OBJECTIVES:

Primary

Correlate the dynamic contrast-enhanced (DCE)-MRI contrast kinetic parameter K^trans with the histopathologic determination of malignancy by MRI-guided needle biopsy (the access to prostate tissue under MRI guidance system [APT-MRI]) in patients with confirmed or suspected adenocarcinoma of the prostate.

Secondary

Determine the feasibility and tolerability of MRI-guided prostate biopsy with the APT-MRI in these patients.
Determine the ability of the APT-MRI to target all prostatic subzones and all sites of suspicious malignancy within the prostate gland of these patients.
Determine the tissue-targeting accuracy of the APT-MRI for needle biopsy in these patients.
Correlate other DCE-MRI contrast kinetic parameters, such as V^f, amplitude, slope, and time to peak, with the histopathologic determination of malignancy by APT-MRI in these patients.
Correlate the subjective determination of malignant sites within the prostate gland by DCE-MRI images, T2W images, or both, with the histopathologic determination of malignancy by APT-MRI in these patients.
Compare DCE-MRI data with the microvessel density of corresponding tissues in these patients.
Compare DCE-MRI data with the microarray and proteomic profiles of corresponding tissues in these patients.
Compare the histopathologic diagnosis and Gleason grade obtained by APT-MRI with prior transrectal ultrasonography-guided biopsy results in these patients.
Compare the Gleason grade obtained by APT-MRI biopsies with the Gleason grade obtained by prostatectomy specimens.
Compare DCE-MRI results with serum prostate-specific antigen levels and serum and/or urine proteomic profiles of these patients.

Tertiary

Determine, preliminarily, measures of change in DCE-MRI images during therapy in these patients.

OUTLINE: Patients undergo endorectal coil MRI of the prostate gland comprising conventional anatomic imaging and dynamic contrast-enhanced MRI using gadopentetate dimeglumine. During the MRI procedure, 4-10 needle biopsy cores of the prostate are obtained using a transrectal needle guidance system (access to prostate tissue under MRI [APT-MRI]). APT-MRI may be repeated at a later time during observation or during or after prostate cancer treatment.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Definitive local therapy has not been initiated
- Biopsy result will not affect subsequent surgical management of disease OR
Suspected prostate cancer by transrectal ultrasonography within the past 12 months

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Platelet count > 50,000/mm^3
No bleeding disorder

Hepatic

PT/PTT < 1.5 times upper limit of normal

Renal

Not specified

Immunologic

No allergy to magnetic resonance contrast agent
No allergy to local anesthetics
No allergy to quinolone antibiotics
Not severely immunocompromised

Other

Weight ≤ 136 kg
No severe hemorrhoids
No other medical condition that would preclude study participation
No surgically absent rectum
No pacemaker, cerebral aneurysm clips, shrapnel injury, or implantable electronic device that would preclude MRI

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent prostate-specific antigen vaccine therapy allowed

Chemotherapy

Not specified

Endocrine therapy

Concurrent hormonal therapy allowed

Radiotherapy

Concurrent radiotherapy allowed

Surgery

No other prostate biopsy for 3 weeks before and 1 week after study participation
Prostatectomy may be performed 2-4 weeks after study participation

Other

No concurrent anticoagulation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085514

Locations

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000370813, NCI-04-C-0171
Study First Received:	June 10, 2004
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00085514
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer

stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Signs and Symptoms
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009