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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02588404
• Other study ID #: fusion study
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2015
• Last updated: July 27, 2016
• Start date: December 2016

Study information

• Verified date: July 2016
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: One of the following

• T3a +

• PSA > 20

• Gleason 8 or higher

• Karnofsky performance status = 70.

• Signed study-specific informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with biochemical failure showing presence of TMPRSS2-ERG gene fusion.	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	No