MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy
Primary Purpose
Recurrent Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI-Guided Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Recurrent Prostate Cancer focused on measuring prostate cancer, magnetic resonance imaging, guided imagery
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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI guided prostate biopsy
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint is a preliminary estimate of the diagnostic accuracy of MRI in identifying sites of recurrent tumor after radiotherapy for prostate cancer.
Secondary Outcome Measures
Full Information
NCT ID
NCT00775866
First Posted
October 16, 2008
Last Updated
November 27, 2017
Sponsor
University Health Network, Toronto
Collaborators
U.S. Army Medical Research and Development Command, Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00775866
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
U.S. Army Medical Research and Development Command, Princess Margaret Hospital, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer
Keywords
prostate cancer, magnetic resonance imaging, guided imagery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI guided prostate biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI-Guided Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is a preliminary estimate of the diagnostic accuracy of MRI in identifying sites of recurrent tumor after radiotherapy for prostate cancer.
Time Frame
at the end of the evaluation phase
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Chung, MB ChB
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25203127
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.
Results Reference
background
Learn more about this trial
MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy
We'll reach out to this number within 24 hrs