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

NCT ID: NCT02588404

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2030-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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LHRH therapy

These patients will be treated with LHRH agonist as standard therapy.

Intervention Type DRUG

Other Intervention Names

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Eligard, Lupron, Trelstar, and Zoladex

Eligibility Criteria

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Inclusion Criteria

* T3a +
* PSA \> 20
* Gleason 8 or higher
* Karnofsky performance status ≥ 70.
* Signed study-specific informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tamim Niazi

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Fusion study

Identifier Type: -

Identifier Source: org_study_id