The Predictive Value of Coexisting TMPR… | Clinical Trial

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi, Chicoutimi, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

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

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Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2027
First posted: Oct 12, 2015
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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