MRI-Guided HDR Brachytherapy for Prostate Cancer
Condition: Patients With Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT00913939
Sponsor: University Health Network, Toronto
- Age: minimum 18 Years maximum N/A
- Gender: Male
- Prior enrollment of UHN 05-0641-C or UHN 12-5015-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.
- 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.
View trial on ClinicalTrials.gov