High-Dose-Rate Brachytherapy

May 7, 2023 updated by: University Health Network, Toronto

MRI-Guided HDR Brachytherapy for Prostate Cancer

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. In Arm 1, 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). In arm 2, patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.

This technique will be prospectively evaluated in up to 100 patients. Preliminary data acquired in this pilot study will determine the technical limits of MRI guided HDR brachytherapy and will be critical for the judicious conduct of a subsequent phase II clinical trial.

This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor targeting for HDR brachytherapy. Successful completion of this study will further individualize local therapy, not only for the benefit of the proportion of cancer patients for whom initial radiotherapeutic interventions have failed, but also provide valuable technical and clinical validation that these novel image-guided (IG) approaches are clinically feasible and could be applied more broadly in prostate cancer therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Two hundred and nineteen thousand new cases of prostate cancer have been projected in the Unites States for 2007, with external beam radiotherapy (EBRT) constituting the mainstay of local therapy for an increasing proportion of newly diagnosed patients. Despite improvements in the delivery and reduction in associated toxicity of external beam radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of patients. Local disease after EBRT is a risk factor for subsequent metastatic progression and prostate cancer-specific mortality, and is a cause of morbidity including hematuria, obstructive uropathy, and chronic pain. Given its prevalence, and the lack of satisfactory local salvage treatments, fear of prostate cancer recurrence has been shown to impose a substantial burden of suffering in patients.

Stereotactic needle placement under MRI-guidance enables two critical steps in tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor recurrence, and 2) permitting treatment planning and delivery to be based on 3D MRI images. MRI-based HDR brachytherapy will precisely identify the location of brachytherapy catheters relative to the target volumes and adjacent normal structures at risk of radiation injury, obviating the need for invasive saturation (24-100) mapping biopsies.

This study will build the evidence supporting the concept of MRI-guidance and tumor-targeted HDR brachytherapy in the management of prostate cancer. This trial will strive to demonstrate improvements in technical performance under MRI-guidance, while exploring a novel paradigm of patient-specific modulation of dose intensity based on regions of tumor burden.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1: Salvage After EBRT
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).
Procedure: MRI Guided Needles to deliver HDR Brachytherapy
Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).
Procedure: MRI Guided Needles to deliver HDR Brachytherapy
Patients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT.
Active Comparator: 2: Boost to EBRT
Patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.
Procedure: MRI Guided Needles to deliver HDR Brachytherapy
Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).
Procedure: MRI Guided Needles to deliver HDR Brachytherapy
Patients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 5 years
5 years
determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Peter Chung, MB ChB, University Health Network, Princess Margaret Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 09-0026-C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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