Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer

NCT00082147 | Completed

• 2 other identifiers: 04017104-C-0171
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 When the needle is in place, a small tissue sample is withdrawn.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.

Conditions

Prostate Cancer

Keywords

MRI; Biopsy; Fiducial Marker; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation between the DCE-MRI kinetic parameter Ktrans and histopathologic determination of malignancy at corresponding biopsy sites within the prostate gland.

  Post procedure

Secondary Outcomes (9)

• To further determine the feasibility and tolerability of MRI-guided prostate biopsy with the APTMRI system.

  completion of study

• To determine the ability of the APT-MRI system to target all prostatic subzones and all sites suspicious of malignancy within the prostate gland.

  completion of study

• To obtain further data on the tissue targeting accuracy of the APT-MRI system for needle biopsy

  completion of study

• To determine if other DCE-MRI contrast kinetic parameters (Vf, amplitude, slope, and time to peak) correlate with the histopathologic determination of malignancy based on MRI-guided needle biopsies of the prostate gland.

  completion of study

• To determine if the subjective determination of malignant sites within the prostate gland based on DCE-MR images, T2W images, or both, correlates with the histopathologic determination of malignancy based on MRI-guided needle biopsies.

  completion of study

Study Arms (1)

Biopsy

EXPERIMENTAL

Biopsy

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Patients will then undergo endorectal coil MR imaging of the prostate gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI During MR imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal needle guide system (APT-MRI).

Biopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0 or 1.
• Patients with a TRUS-guided biopsy for suspected prostate cancer in the past twelve months, or patients with pathologically confirmed adenocarcinoma of the prostate gland and who have not received definitive local therapy.
• Age greater than or equal to 18 years.
• 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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.

  PMID: 12226149 BACKGROUND

• Potosky AL, Legler J, Albertsen PC, Stanford JL, Gilliland FD, Hamilton AS, Eley JW, Stephenson RA, Harlan LC. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92. doi: 10.1093/jnci/92.19.1582.

  PMID: 11018094 BACKGROUND

• Rabbani F, Stroumbakis N, Kava BR, Cookson MS, Fair WR. Incidence and clinical significance of false-negative sextant prostate biopsies. J Urol. 1998 Apr;159(4):1247-50.

  PMID: 9507846 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 30, 2004
• First Posted: April 30, 2004
• Study Start: April 29, 2004
• Study Completion: June 11, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06-11

Locations

US (1)