Salvage Prostatectomy After Radiotherapy

NCT00791115 | Completed DMC

• 2 other identifiers: UHN REB 08-0350-CENIH CA12156
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Prostate cancer; prostatectomy; radiotherapy; prostatectomy after radiotherapy

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

• Preliminary evaluation of surgical margin status, toxicity and QOL, and biochemical control after salvage RP.

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

Study Arms (1)

prostatectomy after radiotherapy

EXPERIMENTAL

Procedure: whole-mount sectioning of the prostate

Interventions

whole-mount sectioning of the prostate 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

prostatectomy after radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cynthia Ménard, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: June 1, 2008
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

CA (1)