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
  Purpose

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).


Condition Intervention
Prostate Cancer
Procedure: whole-mount sectioning of the prostate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prostatectomy after radiotherapy 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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791115

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00791115     History of Changes
Other Study ID Numbers: UHN REB 08-0350-CE, NIH CA12156
Study First Received: November 13, 2008
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Prostate cancer
prostatectomy
radiotherapy
prostatectomy after radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014