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High-Dose-Rate Brachytherapy

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ClinicalTrials.gov Identifier: NCT00913939
Recruitment Status : Recruiting
First Posted : June 4, 2009
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date December 2, 2019
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
To determine if MRI-guided HDR brachytherapy is associated with favorable measures of technical performance. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • 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 ]
  • determine dose-response relationships for salvage brachytherapy with a 20% escalation in dose. [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose-Rate Brachytherapy
Official Title  ICMJE MRI-Guided HDR Brachytherapy for Prostate Cancer
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients With Prostate Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: MRI Guided Needles to deliver HDR Brachytherapy
  • 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.
    Intervention: Procedure: MRI Guided Needles to deliver HDR Brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2019)
400
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
60
Estimated Study Completion Date  ICMJE May 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Chung, MB ChB 416 946 4501 ext 6522 Peter.chung@rmp.uhn.on.ca
Contact: Cynthia Ménard, MD 514 890-8000 ext 24684 cynthia.menard.chum@ssss.gouv.qc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913939
Other Study ID Numbers  ICMJE UHN REB 09-0026-C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Princess Margaret Hospital, Canada
Investigators  ICMJE
Principal Investigator: Peter Chung, MB ChB University Health Network, Princess Margaret Hospital
PRS Account University Health Network, Toronto
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP