Know Cancer

or
forgot password

MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study


OBJECTIVES:

- 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.

- Compare the incremental benefit of these tests on diagnostic accuracy in these
patients.

- Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the
localization of prostate cancer in these patients.

- 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.

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.

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

Inclusion 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)

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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Jeffrey Weinreb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000069254

NCT ID:

NCT00032058

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Brigham and Women's HospitalBoston, Massachusetts  02115