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Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy

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 tumor-targeted salvage HDR
brachytherapy, by providing further histopathological validation of the method.

Inclusion Criteria:

- Prior enrollment of UHN 05-0641-C

- Histological evidence of cancer on MRI-guided prostate biopsy

- PSA doubling time > 6 months

- ECOG 0 or 1

- All patients must give written informed consent indicating their understanding of the
investigational nature and risks of the study before any protocol related studies are

Exclusion Criteria:

- Contraindications to salvage prostatectomy

- Previous rectal surgery for IBD or cancer such that an ileo-anal anastomosis is

- Radiological evidence of regional or distant metastases

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To Validate virtual dosimetry plans for tumor-targeted salvage (High-Dose-Rate) HDR brachytherapy against co-registered whole-mount prostatectomy specimens.

Outcome Time Frame:

Patients will have follow-up assessments at 1,3 and 6 months and 1,2,3 and 5 years after surgery.

Safety Issue:


Principal Investigator

Cynthia Ménard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:

UHN REB 08-0350-CE



Start Date:

June 2008

Completion Date:

June 2014

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • prostatectomy
  • radiotherapy
  • prostatectomy after radiotherapy
  • Prostatic Neoplasms