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Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

Phase 2
18 Years
80 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer

The objective of this study is to evaluate of the potential of endorectal 3T MRI for the
staging of prostate cancer before prostatectomy or recurrence of prostate cancer after

Inclusion Criteria:

- Age of patients: up to 80 years.

- Men scheduled for radical prostatectomy due to prostate cancer or men post radical
prostatectomy with suspicion of recurrence.

- Patients who are able and willing to give consent and able to have an MRI

Exclusion Criteria:

- Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted
ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast
agent (e.g. Gadolinium or Dotarem)

- Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during imaging (approximately 1 hr.)

- Any rectal pathology preventing probe insertion, (as active proctitis, active
ulcerative colitis, fissure ani)

- Any spinal pathology that prohibits maintaining supine position for an hour

- Patients with documented myocardial infarction within one month of protocol entry,
and patients with cardiac pacemakers

- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

• MRI and pathology correlation

Outcome Time Frame:

2 years

Safety Issue:



Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

November 2008

Completion Date:

June 2011

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms