Condition: Patients With Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00913939

Sponsor: University Health Network, Toronto

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 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.

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.

View trial on ClinicalTrials.gov