Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

This study will examine the usefulness of an imaging procedure called dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how the medicine flows through the prostate gland. The measurements provide information about the blood vessels in the prostate gland, which provides other information about the cancer. Several needle biopsies are performed during the procedure, and the results of the biopsies are compared with the information from the DCE-MRI. Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for this study. Candidates are screened with a medical history and physical examination, blood test, and review of tumor pathology. Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the morning of the procedure, patients are given an antibiotic called Levofloxacin. They also have a small enema the morning of the test. A local anesthetic is then given in the area around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube is placed in the rectum to obtain better pictures of the prostate gland during the imaging. During the scan, the patient may be asked to breathe air that contains higher concentrations of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the rectum into the prostate gland. When the needle is in place, a small tissue sample is withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure, which lasts about 1 hour, the patient lies on his stomach on a stretcher. Patients who are planning to undergo surgery or radiation treatment for their cancer at the NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the DCE-MRI procedure. The markers are left in place to help target the radiation treatments and to show where the biopsies were taken if the prostate is removed. At the end of the procedure, the patient is moved to a bed to recover and may get up and urinate after about 30 to 60 minutes. After a period of observation, the patient is discharged home with a dose of antibiotic to take the next day. Some patients may be asked to repeat the MRI and biopsy procedure during or after their treatment for prostate cancer to help investigators learn whether the MRI test is still helpful after treatment. Repeat testing is optional.

Key facts

Study ID

NCT00082147

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2004-04-29

Expected to finish

2018-06-11

Last updated by the study team

2018-06-13

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Contraindication to trans-rectal biopsy:
• Bleeding disorder;
• PT/PTT greater than or equal to 1.5 times the upper limit of normal;
• Platelets less than or equal to 50K;
• Active anticoagulation;
• Severe immunocompromise;
• Severe hemorrhoids;
• Surgically absent rectum.
• Contraindication to MRI:
• Patients weighing greater than 136 kgs (weight limit for the scanner tables);
• Allergy to MR contrast agent;
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
• Allergy to local anesthetics or quinolone antibiotics.
• Patients with a known diagnosis of prostate cancer and a known treatment plan to proceed to prostatectomy if the result of the biopsy would not affect surgical management.
• Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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