Characterization of Prostate Cancer With 3T MR

NCT00831142 | Active Not Recruiting

• 2 other identifiers: 2006P0001545R01CA116465-04
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In so doing, it may be possible to further improve the numbers and percentage of cancer patients who receive effective therapy that will cure the disease and maximize their quality of life following therapy.

• Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
• Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
• Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRI; Prostatectomy

Study Arms (1)

Prostate Cancer

Males with prostate cancer, referred for biopsy or radical prostatectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample will include 50 male patients per year of all races and ethnic origins over 40 years of age who are likely to undergo radical prostatectomy for prostate carcinoma. Patients will be imaged using MRI/MRS.

You may qualify if:

• Biopsy-proven adenocarcinoma of the prostate.
• Written documentation from the urologist stating the anticipation that the patient will undergo radical prostatectomy or biopsy of the prostate within six months of MRI.
• The interval between biopsy and protocol MRI must not be less than 2 weeks.
• Pathologic specimens from radical prostatectomy must be provided for whole mount analysis.
• Patients will sign a study-specific consent prior to study entry.
• Men above the age of 40 years old

You may not qualify if:

• Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
• Patients unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
• Patients who cannot tolerate or have contra-indications to ERC insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease.
• Patients with an allergic reaction to latex.
• Cryosurgery, surgery for prostate cancer including TURP, prostatic radiotherapy, including bradiotherapy for rectal cancer, androgen deprivation therapy, rectal surgery, or alternative medicine prior to radical prostatectomy.
• Any metallic implant (e.g. hip) or device that might distort local magnetic field and compromise quality of MRI.
• Radical prostatectomy or biopsy of the prostate not planned to be performed within six (6) months of protocol MRI.
• Patients who have undergone BCG for bladder cancer.
• Patients with severe motion artifacts rendering the data unusable.
• Patients who have an allergic history to gadopentetate dimeglumine administration.
• Patients with a contraindication to the administration of glucagon (pheochromocytoma, islet pancreatic tumor, or insulin-dependent diabetes) or a prior history of allergic reaction following glucagon administration.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• David C Alsop, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MR Research

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: June 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: May 31, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)