Clinical trial for Patients With Prostate Cancer
Official title High-Dose-Rate Brachytherapy
ClinicalTrials.gov ID: NCT00913939
What this study is testing
- What it's testing
- The study aims to evaluate the safety and technical feasibility of MRI‑guided high‑dose‑rate (HDR) brachytherapy in two groups of prostate cancer patients.
- Who it's for
- Men with prostate cancer who either have locally recurrent disease after prior radiotherapy or have locally advanced disease.
- What's involved
- Participants will receive targeted HDR brachytherapy guided by MRI, either as a salvage treatment after previous radiotherapy or as a boost during external beam radiotherapy. The procedure involves imaging, needle placement, and delivery of a high‑dose radiation dose directly to the tumor.
- Time commitment
- The study will last until the planned number of patients is enrolled, with each participant undergoing a series of imaging and treatment visits as scheduled by the research team.
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 is enrolling
- 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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.