NCT00913939Recruiting
High-Dose-Rate Brachytherapy
MRI-Guided HDR Brachytherapy for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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 in two cohorts of patients. In Arm 1, patients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy. This technique will be prospectively evaluated in up to 500 patients. Preliminary data acquired in this pilot study will determine the technical limits of MRI guided HDR brachytherapy and will be critical for the judicious conduct of a subsequent phase II clinical trial. This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor targeting for HDR brachytherapy. Successful completion of this study will further individualize local therapy, not only for the benefit of the proportion of cancer patients for whom initial radiotherapeutic interventions have failed, but also provide valuable technical and clinical validation that these novel image-guided (IG) approaches are clinically feasible and could be applied more broadly in prostate cancer therapy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 2 Jun 2009
- Start date
- May 2009
- Primary completion date
- May 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT00913939
What you commit to
- Study type: Interventional
- Planned participants: 500
- From May 2009 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate brachytherapy
- Active hormonal therapy at time of brachytherapy (Arm 1)
- Previous pelvic radiotherapy (Arm 2)
- Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery.
Other illness
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
- Latex Allergy
- History of Ulcerative Colitis and SLE (except for patients where the clinician determines benefit outweighs the risk of radiation)
- Other medical conditions deemed by the PI to make patient ineligible for MRI-guided Prostate HDR brachytherapy.
Other
- Radiological evidence of regional or distant metastases
- Contraindications to MRI (Patient weight as per MRI Technologist's discretion, Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI)
- 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 (Arm 2, whole gland HDR patients only)
Who the study is looking for
- 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)
- Intermediate and High-risk localized prostate cancer (\>T1 or PSA\>10 or Gleason \> 6) (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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.