MRI-guided high-dose-rate brachytherapy for prostate cancer
MRI-Guided HDR Brachytherapy for Prostate Cancer
This study is testing a new MRI-guided treatment for prostate cancer to see if it helps patients with recurring or advanced cases feel better and improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT00913939 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the technical and clinical performance of a novel MRI-guided high-dose-rate (HDR) brachytherapy procedure for prostate cancer. It involves two patient cohorts: one receiving tumor-targeted salvage HDR brachytherapy for locally recurrent prostate cancer after prior radiotherapy, and another receiving an HDR boost during external beam radiotherapy for locally advanced prostate cancer. The study aims to assess the feasibility and effectiveness of this approach in improving treatment outcomes. Up to 100 patients will be enrolled to gather preliminary data that will inform future clinical trials.
Who should consider this trial
Good fit: Ideal candidates include men with recurrent prostate adenocarcinoma or high-risk localized prostate cancer who meet specific eligibility criteria.
Not a fit: Patients with evidence of regional or distant metastases or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent or advanced prostate cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing MRI-guided techniques for cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- University Health Network, Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Peter Chung, MB ChB — University Health Network, Princess Margaret Hospital
- Study coordinator: Peter Chung, MB ChB
- Email: Peter.chung@rmp.uhn.on.ca
- Phone: 416 946 4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.