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Brachytherapy
MRI-Guided HDR Brachytherapy for Prostate Cancer
N/A
Recruiting
Led By Peter Chung, MB ChB
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological evidence of recurrent prostate adenocarcinoma (Arm 1)
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new, MRI-guided, high-dose-rate prostate brachytherapy procedure in two cohorts of patients with either locally recurrent or locally advanced prostate cancer. The trial will prospectively evaluate the technique in up to 100 patients to determine the technical limits and clinical feasibility of the new procedure.
Who is the study for?
This trial is for men over 18 with prostate cancer. Arm 1 includes those who've had local recurrence after radiotherapy and a PSA doubling time over 6 months. Arm 2 targets patients with advanced prostate cancer needing an HDR brachytherapy boost during external beam radiotherapy. Participants must be in good physical condition (ECOG score of 0 or 1) and understand the study's risks.Check my eligibility
What is being tested?
The trial tests MRI-guided needles delivering high-dose-rate (HDR) brachytherapy to treat prostate cancer, either as salvage therapy for recurrent cases post-radiotherapy (Arm 1), or as a targeted boost in conjunction with external beam radiotherapy for advanced cases (Arm 2).See study design
What are the potential side effects?
Potential side effects may include discomfort at the needle insertion site, bleeding, infection risk from the procedure, reactions to sedation or anesthesia used during treatment, and typical radiation-related symptoms such as fatigue or urinary issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has come back.
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I am older than 18 years.
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My prostate cancer is high-risk with a stage greater than T2, Gleason score over 7, or PSA over 20.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.
Secondary outcome measures
determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose.
determine if prostate targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance as boost to EBRT;if tumor-targeted & MRI-guided HDR BT is associated with favorable preliminary measures of clinical performance
Trial Design
2Treatment groups
Active Control
Group I: 1: Salvage After EBRTActive Control1 Intervention
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).
Group II: 2: Boost to EBRTActive Control1 Intervention
Patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,604 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,400 Patients Enrolled for Prostate Cancer
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,659 Total Patients Enrolled
10 Trials studying Prostate Cancer
9,916 Patients Enrolled for Prostate Cancer
Peter Chung, MB ChBPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
3 Previous Clinical Trials
197 Total Patients Enrolled
1 Trials studying Prostate Cancer
85 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I weigh less than 136kg and do not have a pacemaker, metal implants, or shrapnel injuries.More than half of a specific area is affected by my cancer.I have had pelvic radiotherapy before.I cannot have an MRI with an endorectal coil due to medical reasons.I cannot have certain types of anesthesia due to health reasons.I have had a significant tissue removal from my prostate.I have had a prostate surgery within the last 6 months.My prostate is larger than 80cc.I have a history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or Lupus.My doctor thinks I shouldn't have MRI-guided prostate therapy due to other health issues.My prostate cancer has come back.I am older than 18 years.I cannot stop my blood-thinning medication for a short period.I have had seed implant radiation therapy for prostate cancer.I am currently on hormone therapy.My prostate cancer is high-risk with a stage greater than T2, Gleason score over 7, or PSA over 20.I am scheduled for external beam radiation therapy with a high-dose-rate boost, with or without hormone therapy.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: 1: Salvage After EBRT
- Group 2: 2: Boost to EBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this research study?
"Affirmative. The information available on clinicaltrials.gov points to this trial, which was initially listed on May 1st 2009, presently looking for participants. 400 patients from a single site are required in order to reach completion of the study."
Answered by AI
Are there any unfilled positions for participants in this clinical trial?
"Affirmative. According to the information on clinicaltrials.gov, enrollment for this research is presently open; having been initially posted on May 1st 2009 and most recently refreshed on October 20th 2022. The study requires 400 patients from a single medical facility"
Answered by AI
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