The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient

December 5, 2024 updated by: Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital

The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient with Biochemical Failure Status Post Salvage or Radical Radiation Therapy (PCS VIII)

The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in prostate patients who have been treated with hormonal and radiation treatment after biochemical failure

Original biopsy slides of 65 patients will be collected and reviewed. A tissue used to test and map DNA fragments will be constructed from patients who underwent radiation therapy. RNA and DNA will be extracted from each slide. This study, if positive, will establish the predictive value of TMPRSS2-ERG gene fusion in prostate cancer patients. It can lead to believe that high-risk prostate cancer patients will benefit from a more aggressive treatment.

An endpoint of this study is to evaluate the relation between the Gleason score and the TMPRSS2-ERG gene fusion. Another is to evaluate the relation between the T-stage and TMPRSS2-ERG gene fusion.

Study Type

Observational

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

Sampling Method

Non-Probability Sample

Study Population

The original slides of 65 patients with informed consent will be reviewed. Assuming 50% Gene-fusion carrier rate, 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. The block must be clearly labeled with the protocol and case number. A tissue microarray (TMA) containing cores representing clinically localized prostate cancers will be constructed from 60 men who underwent radical radiation therapy. Three cores (0.6mm in diameter) will be taken from each representative tissue block to construct the TMA. Detailed clinical, pathological, and TMA data will be maintained on a secure database.

Description

Inclusion Criteria: One of the following

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with biochemical failure showing presence of 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) will be tested to evaluate the predictive value of the TMPRSS2-ERG gene fusionThe 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)

December 1, 2015

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimated)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fusion study

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

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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