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MRI/MRSI in Risk Assessment of Prostate Cancer Patients

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Prostate Cancer

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Trial Information

MRI/MRSI in Risk Assessment of Prostate Cancer Patients

In this study, patients with low-risk, organ-confined prostate cancer identified in clinic
or prior to their already scheduled standard of care MRI in the Department of Radiology will
be approached for the study. Eligible patients will undergo a baseline eMRI/MRSI exam
between 6 and 24 weeks following biopsy. Patients will undergo definitive treatment (radical
prostatectomy (RP) or radiation therapy (RT)) or will be placed on deferred therapy.
Predictor variables will be recorded for each patient after enrollment, before treatment and
during treatment follow-up. Patient outcome-disease progression will be determined by long
term clinical follow-up

Inclusion Criteria:

1. Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer

2. Clinically low-risk localized disease as defined by NCCN guidelines (clinical stage
T1-T2a, maximum Gleason score 2-6, peak serum PSA level < 10 ng/ml)

3. No evidence of disseminated disease (bone or lymph node metastases)

4. Treatment—radical prostatectomy, radiation therapy, or deferred therapy—will be at

5. Willingness to undergo serial surveillance TRUS-guided prostate biopsies and
eMRI/MRSI examination at MSKCC if placed on deferred therapy protocol

6. In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six
months of eMRI/MRSI study

Exclusion Criteria:

1. Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy
or cryosurgery)

2. Inability to give informed consent because of age, general medical or psychiatric
condition, or physiologic status

3. Presence of known contraindication to eMRI

4. Unwillingness or inability to undergo placement of endorectal MR coil or ultrasound
probe. As is the case for a standard MR exam, the presence of a pacemaker or aneurysm
clips could pose a risk to patients, making them unable to have an eMRI, and
therefore unable to participate in this study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

In a population of patients designated as clinically indolent by NCCN guidelines, we will evaluate the ability of eMRI/MRSI to predict pathologically indolent cancer. eMRI/MRSI findings will be compared with step-section pathology.

Outcome Time Frame:

October 2010

Safety Issue:


Principal Investigator

Hedvig Hricak, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

October 2011

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostate
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021