MRI-Guided HDR Brachytherapy for Prostate Cancer
18 Years
N/A
Male
Patients With Prostate Cancer
Trial Information
MRI-Guided HDR Brachytherapy for Prostate Cancer
Two hundred and nineteen thousand new cases of prostate cancer have been projected in the
Unites States for 2007, with external beam radiotherapy (EBRT) constituting the mainstay of
local therapy for an increasing proportion of newly diagnosed patients. Despite
improvements in the delivery and reduction in associated toxicity of external beam
radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of
patients. Local disease after EBRT is a risk factor for subsequent metastatic progression
and prostate cancer-specific mortality, and is a cause of morbidity including hematuria,
obstructive uropathy, and chronic pain. Given its prevalence, and the lack of satisfactory
local salvage treatments, fear of prostate cancer recurrence has been shown to impose a
substantial burden of suffering in patients.
Stereotactic needle placement under MRI-guidance enables two critical steps in
tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor
recurrence, and 2) permitting treatment planning and delivery to be based on 3D MRI images.
MRI-based HDR brachytherapy will precisely identify the location of brachytherapy catheters
relative to the target volumes and adjacent normal structures at risk of radiation injury,
obviating the need for invasive saturation (24-100) mapping biopsies.
This study will build the evidence supporting the concept of MRI-guidance and tumor-targeted
HDR brachytherapy in the management of prostate cancer. This trial will strive to
demonstrate improvements in technical performance under MRI-guidance, while exploring a
novel paradigm of patient-specific modulation of dose intensity based on regions of tumor
burden.
Inclusion Criteria:
- Prior enrollment of UHN 05-0641-C (Arm 1)
- Histological evidence of recurrent prostate adenocarcinoma (Arm 1)
- PSA doubling time > 6 months (Arm 1)
- High-risk localized prostate cancer (>T2 or G>7 or PSA>20) (Arm 2)
- Planned for EBRT + HDR boost (+/- hormone therapy) (Arm 2)
- ECOG 0 or 1
- Age > 18 years
- Informed consent: All patients must sign a document of informed consent indicating
their understanding of the investigational nature and risks of the study before any
protocol related studies are performed.
Exclusion Criteria:
- Radiological evidence of regional or distant metastases
- Contraindications to MRI (Patient weighing >136kg (scanner weight limit), Patients
with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic
devices not compatible with MRI)
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased
during brachytherapy
- Previous prostate brachytherapy
- Active hormonal therapy (Arm 1)
->50% of contiguous sextants involved with tumor (Arm 1)
- Previous pelvic radiotherapy (Arm 2)
- Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or
colorectal surgery.
- Latex Allergy
- Contraindications to conscious sedation, local anesthesia, or spinal/epidural
anesthesia.
- IPSS >18
- Large TURP defect
- TURP within the past 6 months
- Prostate gland size >80cc
- History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
- Other medical conditions deemed by the PI to make patient ineligible for MRI-guided
Prostate HDR brachytherapy.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Cynthia Menard, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Research Ethics Committee
Study ID:
UHN REB 09-0026-C
NCT ID:
NCT00913939
Start Date:
May 2009
Completion Date:
May 2014
Related Keywords:
- Patients With Prostate Cancer
- Prostate Cancer
- HDR Brachytherapy
- Prostate Brachytherapy
- Prostatic Neoplasms
Name | Location |
|---|
