Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

MRI in Finding Cancer in Patients With Confirmed or Suspected Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic Closed 18 and over NCI NCI-04-C-0171 NCT00085514

Objectives

Primary

1. 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

1. Determine the feasibility and tolerability of MRI-guided prostate biopsy with the APT-MRI in these patients.
2. 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.
3. Determine the tissue-targeting accuracy of the APT-MRI for needle biopsy in these patients.
4. 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.
5. 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.
6. Compare DCE-MRI data with the microvessel density of corresponding tissues in these patients.
7. Compare DCE-MRI data with the microarray and proteomic profiles of corresponding tissues in these patients.
8. Compare the histopathologic diagnosis and Gleason grade obtained by APT-MRI with prior transrectal ultrasonography-guided biopsy results in these patients.
9. Compare the Gleason grade obtained by APT-MRI biopsies with the Gleason grade obtained by prostatectomy specimens.
10. Compare DCE-MRI results with serum prostate-specific antigen levels and serum and/or urine proteomic profiles of these patients.

Tertiary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Platelet count > 50,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Kevin Camphausen, MD, Principal investigator		Ph: 301-496-5457 Email: camphauk@mail.nih.gov

Related Information

Web site for additional information

Registry Information
Official Title		A Prospective Histopathologic Study of Dynamic Contrast Enhanced MRI for Prostate Cancer Delineation and Characterization with the APT-MRI System
Trial Start Date		2004-05-06
Registered in ClinicalTrials.gov		NCT00085514
Date Submitted to PDQ		2004-05-06
Information Last Verified		2007-05-06