Salvage Prostatectomy After Radiotherapy - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00791115

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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Salvage Prostatectomy After Radiotherapy: Whole-Mount Histopathological Validation for Tumor-Targeted Salvage HDR Brachytherapy

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 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Cynthia Ménard, MD

416-946-4501 ext 6513

cynthia.menard@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Cynthia Ménard, MD 416-946-4501 ext 6513 cynthia.menard@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Cynthia Ménard, MD

University Health Network, Toronto

More Information

Responsible Party:	Universtiy Health Network, Princess Margaret Hospital ( Dr. Cynthia Ménard, Clinician Scientist, Staff Radiation Oncologist )
Study ID Numbers:	UHN REB 08-0350-CE, NIH CA12156
Study First Received:	November 13, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00791115
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Prostate cancer
prostatectomy
radiotherapy
prostatectomy after radiotherapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009