High-Dose-Rate Brachytherapy
Recruiting · NCT00913939 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
- 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.
Exclusion criteria
- 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)
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
- 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.
- 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 (Arm 2, whole gland HDR patients only)
- 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.
Where it is running
1 location listed.
- University Health Network, Princess Margaret Hospital - Toronto, Ontario, Canada