Status:
RECRUITING
High-Dose-Rate Brachytherapy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Patients With Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This pilot study initiates a research program testing the early technical and clinical performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy. Testing will proceed...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00913939
Start Date
May 1 2009
End Date
May 1 2025
Last Update
June 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9