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

Alternate Title

Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer

Basic Trial Information

Objectives

1. Compare the accuracy of MRI vs MRI combined with magnetic resonance spectroscopic imaging (MRSI) for the localization of prostate cancer prior to radical prostatectomy in patients with stage I or II adenocarcinoma of the prostate.
2. Compare the incremental benefit of these tests on diagnostic accuracy in these patients.
3. Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the localization of prostate cancer in these patients.
4. Compare the accuracy of combined MRSI with that of other available information on tumor extent derived from digital rectal exam, PSA level, Gleason score, and Partin nomogram in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage I-II adenocarcinoma of the prostate
  • At least 6 weeks since prior biopsy

• Scheduled to undergo radical prostatectomy within 6 months of MRI and magnetic resonance spectroscopic imaging (MRSI)

Prior/Concurrent Therapy:

Biologic therapy:

• No prior BCG for bladder cancer

Chemotherapy:

• Not specified

Endocrine therapy:

• No prior androgen-deprivation therapy

Radiotherapy:

• No prior prostatic or rectal radiotherapy

Surgery:

• See Disease Characteristics
• No prior cryosurgery
• No prior surgery for prostate cancer
• No prior transurethral resection of the prostate (TURP)
• No prior rectal surgery

Other:

• No prior complementary alternative medicine

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No cardiac pacemakers

Other:

• Must be willing and able to undergo MRI/MRSI
• No allergy to latex
• No contraindications to MRI such as non-compatible intracranial vascular clips
• No metallic hip implant or any other metallic implant or device that would compromise quality of MRI/MRSI
• No contraindications to or intolerance of endorectal coil insertion (e.g., prior abdominoperineal resection of the rectum or Crohn's disease)
• No general medical or psychiatric condition or physiologic status unrelated to prostate cancer that would preclude valid informed consent

Expected Enrollment

A total of 134 patients will be accrued for this study within 7 months.

Outline

This is a multicenter study.

At least 6 weeks after biopsy, patients undergo MRI and magnetic resonance spectroscopic imaging (MRSI) over approximately 1 hour. Within 6 months of MRI/MRSI, patients undergo radical prostatectomy.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Jeffrey Weinreb, MD, Protocol chair		Ph: 203-785-5913 Email: jeffrey.weinreb@yale.edu

Registry Information
Official Title		MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study
Trial Start Date		2003-06-26
Trial Completion Date		2006-06-14
Registered in ClinicalTrials.gov		NCT00032058
Date Submitted to PDQ		2002-01-25
Information Last Verified		2005-04-26
NCI Grant/Contract Number		CA080098

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