Salvage Prostatectomy After Radiotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00791115
First received: November 13, 2008
Last updated: June 24, 2014
Last verified: June 2014

November 13, 2008
June 24, 2014
June 2008
June 2015   (final data collection date for primary outcome measure)
To Validate virtual dosimetry plans for tumor-targeted salvage (High-Dose-Rate) HDR brachytherapy against co-registered whole-mount prostatectomy specimens. [ Time Frame: Patients will have follow-up assessments at 1,3 and 6 months and 1,2,3 and 5 years after surgery. ] [ Designated as safety issue: No ]
To Validate virtual dosimetry plans for tumor-targeted salvage (High-Dose-Rate) HDR brachytherapy against co-registered whole-mount prostatectomy specimens. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00791115 on ClinicalTrials.gov Archive Site
Preliminary evaluation of surgical margin status, toxicity and QOL, and biochemical control after salvage RP. [ Time Frame: Patients will have follow-up assessments at 1,3 and 6 months and 1,2,3 and 5 years after surgery. ] [ Designated as safety issue: No ]
Preliminary evaluation of surgical margin status, toxicity and QOL, and biochemical control after salvage RP. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Salvage Prostatectomy After Radiotherapy
Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy

The purpose of this study is to compare the location of the cancer found in the prostate gland after it is removed to the location that was predicted on the MRI scan during biopsy. In this way, we can better determine if the Magnetic Resonance Imaging (MRI) was accurate, and if the MRI could be safely used to guide other types of treatments such as brachytherapy. We also plan to carefully measure how frequently surgery is able to completely remove the cancer, as well as the side effects and effectiveness of surgery after radiotherapy. 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 this trial (UHN 05-0641-C).

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Procedure: whole-mount sectioning of the prostate
A standard open retropubic radical prostatectomy will be performed. Whole fresh prostate is be embedded in gel and oriented in the anatomic position in a plastic cylinder using wood skewers. Standard pathology reports are generated from this tissue
Experimental: prostatectomy after radiotherapy
Intervention: Procedure: whole-mount sectioning of the prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
June 2015
June 2015   (final data collection date for primary outcome measure)

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 performed

Exclusion Criteria:

  • Contraindications to salvage prostatectomy
  • Previous rectal surgery for IBD or cancer such that an ileo-anal anastomosis is present.
  • Radiological evidence of regional or distant metastases
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00791115
UHN REB 08-0350-CE, NIH CA12156
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
University Health Network, Toronto
June 2014

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