BridgeMD
New treatment option for Patients With Prostate Cancer
Official title High-Dose-Rate Brachytherapy
ClinicalTrials.gov ID: NCT00913939
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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)
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.