Status:
COMPLETED
MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Princess Margaret Hospital, Canada
Conditions:
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 prosta...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00775866
Start Date
October 1 2006
End Date
September 15 2017
Last Update
November 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network
Toronto, Ontario, Canada, M5G 2M9