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MRI - Guided Biopsy for Suspicion of Locally Recurrent Prostate Cancer After External Beam Radiotherapy

18 Years
Open (Enrolling)
Recurrent Prostate Cancer

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Trial Information

MRI - Guided Biopsy for Suspicion of Locally Recurrent Prostate Cancer After External Beam Radiotherapy

This study involves the technical development and clinical testing of a novel technique for
magnetic resonance imaging (MRI) guided prostate biopsy in a 1.5T horizontal bore scanner
using a dedicated interventional table. We primarily hypothesize that the integration of
diagnostic and interventional MRI enables needle biopsy targeting to foci of tumor
recurrence after radiotherapy, and will enable a determination of the diagnostic accuracy of
MRI in mapping sub-sites of tumor recurrence after radiotherapy. RELEVANCE TO PUBLIC
HEALTH: Patients with recurrence of their prostate cancer after radiotherapy currently face
difficult choices. Standard second line treatments target the entire prostate gland and are
associated many side effects. This study will directly improve the detection, spatial
delineation, and characterization of prostate cancer persistence after radiotherapy. If
anatomic patterns of disease persistence are found across patients, radiation delivery
techniques will be suitably modified, which may translate to improved cure rates.
Importantly, this study will establish a procedural platform for MRI-guidance of minimally
invasive local salvage therapies. By precisely focusing salvage therapy to sites of tumor
persistence within the prostate gland, side effects may be reduced in the future.

Inclusion Criteria:

- Biochemical failure > 18 months after definitive external beam radiotherapy (ASTRO
definition - revised version 2006: rise by 2 ng/mL or more above the nadir PSA)

- PSA <20 prior to initial course of external beam radiotherapy

- PSADT >3 months at failure

- Age ≥ 18 years

- ECOG performance status 0 or 1 with >10 year life expectancy

- Fit for local anaesthesia

- Informed consent:

Exclusion Criteria:

- Contraindications to MRI

- Severe claustrophobia

- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased
precluding brachytherapy

- Previous brachytherapy

- Active hormonal therapy

- Radiologic evidence of LN or distant metastases

- Other urinary or medical conditions deemed by the PI or associates to make the
patient ineligible for MRI-guided prostate biopsy.

- Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or
previous colorectal surgery

- Contraindications to conscious sedation

- Contraindication to IV Gadolinium administration

- latex allergy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary endpoint is a preliminary estimate of the diagnostic accuracy of MRI in identifying sites of recurrent tumor after radiotherapy for prostate cancer.

Outcome Time Frame:

at the end of the evaluation phase

Safety Issue:


Principal Investigator

Cynthia Ménard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:

UHN REB 05-0641-C



Start Date:

October 2006

Completion Date:

October 2013

Related Keywords:

  • Recurrent Prostate Cancer
  • prostate cancer, magnetic resonance imaging, guided imagery
  • Prostatic Neoplasms