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The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients with Biochemical Failure Status Post Salvage or Radical Radiation Therapy

NCT ID: NCT02573636

Last Updated: 2024-12-04

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

RECRUITING

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
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

Locations

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CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi

Chicoutimi, Quebec, Canada

Site Status RECRUITING

CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne

Greenfield Park, Quebec, Canada

Site Status RECRUITING

CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval

Laval, Quebec, Canada

Site Status RECRUITING

CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

Jewish General Hospital, McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

MUHC - Cedars Cancer Center

Montreal, Quebec, Canada

Site Status RECRUITING

CHU - L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Site Status RECRUITING

CIUSSS de l'Estrie - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Site Status NOT_YET_RECRUITING

CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ashley Feng, M.Sc.

Role: CONTACT

[email protected]
514-340-8222 ext. 26510

Facility Contacts

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Hugo Villeneuve, MD

Role: primary

Genevieve Bujold

Role: primary

Marjorie Jolicoeur, MD

Role: backup

Solange Tremblay

Role: primary

Levon Igidbashian, MD

Role: backup

Josée Abi-Saad

Role: primary

Peter Vavassis, MD

Role: backup

Ashley Feng, M.Sc.

Role: primary

[email protected]
514-340-8222 ext. 26510

Tamim Niazi, MD

Role: backup

Marianna Perna

Role: primary

Luis Souhami, MD

Role: backup

Josée Allard

Role: primary

André-Guy Martin, MD

Role: backup

Sophie Couture

Role: primary

Abdenour Nabid, MD

Role: backup

Marie-Eve Caron

Role: primary

Linda-Suzanne Vincent, MD

Role: backup

Other Identifiers

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PCS VIII

Identifier Type: -

Identifier Source: org_study_id