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

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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02588404

Enrollment

Registered

2015-10-27

Start date

2015-12-31

Completion date

2030-01-31

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

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.

Interventions

DRUGLHRH therapy

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

One of the following * T3a + * PSA \> 20 * Gleason 8 or higher * Karnofsky performance status ≥ 70. * Signed study-specific informed consent

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with biochemical failure showing presence of TMPRSS2-ERG gene fusion.	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026