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

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


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