The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

October 19, 2020 updated by: Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.

The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Study Type

Observational

Enrollment (Anticipated)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU - L'Hôtel-Dieu de Québec
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi
        • Principal Investigator:
          • Hugo Villeneuve, MD
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne
        • Contact:
          • Genevieve Bujold
        • Principal Investigator:
          • Marjorie Jolicoeur, MD
      • Laval, Quebec, Canada, H7M 3L9
        • Recruiting
        • CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval
        • Contact:
          • Solange Tremblay
        • Principal Investigator:
          • Levon Igidbashian, MD
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
        • Principal Investigator:
          • Peter Vavassis, MD
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital, McGill University
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • MUHC - Cedars Cancer Center
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Not yet recruiting
        • CIUSSS de l'Estrie - Hôpital Fleurimont
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières
        • Principal Investigator:
          • Linda-Suzanne Vincent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The original slides of 208 patients with informed consent will be reviewed. Patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index.

Description

Inclusion Criteria:

  • T3a +
  • PSA > 20
  • Gleason 8 or higher
  • Karnofsky performance status ≥ 70.
  • Signed study-specific informed consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion.
Time Frame: recruitment over 4 years
Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) who have either clinical progression or 3-year hormonal refractory free survival will be tested to evaluate the predictive value of the coexistence of TMPRSS2-ERG gene fusion and the PTEN deletion. The results between the two groups will be compared to see if either DNA changes are an indicator of LHRH refractoriness
recruitment over 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCS VIII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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