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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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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).

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I weigh less than 136kg and do not have a pacemaker, metal implants, or shrapnel injuries.

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I cannot stop my blood-thinning medication for a short period.

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I have had seed implant radiation therapy for prostate cancer.

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I am currently on hormone therapy.

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More than half of a specific area is affected by my cancer.

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I have had pelvic radiotherapy before.

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I cannot have an MRI with an endorectal coil due to medical reasons.

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I cannot have certain types of anesthesia due to health reasons.

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I have had a significant tissue removal from my prostate.

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My prostate is larger than 80cc.

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I have a history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or Lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 16Eligibility criteria met