Salvage Prostatectomy After Radiotherapy

NCT ID: NCT00791115

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2023-05-12

Brief Summary

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).

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; prostatectomy; radiotherapy; prostatectomy after radiotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prostatectomy after radiotherapy

Group Type: EXPERIMENTAL

whole-mount sectioning of the prostate

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Ménard, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

NIH CA12156

Identifier Type: -

Identifier Source: secondary_id

UHN REB 08-0350-CE

Identifier Type: -

Identifier Source: org_study_id