Clinical trial NCT00775866: MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy
Official title: MRI - Guided Biopsy for Suspicion of Locally Recurrent Prostate Cancer After External Beam Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Prostate Cancer
Keywords: prostate cancer, magnetic resonance imaging, guided imagery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: Princess Margaret Hospital, Canada
First posted: 2008-10-20
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study we will test a new procedure to guide needle biopsies into the prostate gland based on MRI. This study will be conducted in patients who may have recurrence of their cancer in the prostate gland after radiation therapy in order to map out the location of the recurrence. Using this technique, we will be able to measure the accuracy of MR images in identifying the site of tumour recurrence.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: at the end of the evaluation phase
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Peter Chung, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menard C, Iupati D, Publicover J, Lee J, Abed J, O'Leary G, Simeonov A, Foltz WD, Milosevic M, Catton C, Morton G, Bristow R, Bayley A, Atenafu EG, Evans AJ, Jaffray DA, Chung P, Brock KK, Haider MA. MR-guided prostate biopsy for planning of focal salvage after radiation therapy. Radiology. 2015 Jan;274(1):181-91. doi: 10.1148/radiol.14122681. Epub 2014 Sep 8.