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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

NCT02573636 · Sir Mortimer B. Davis - Jewish General Hospital
In plain English

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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.
Eligibility criteria
Inclusion Criteria: * T3a + * PSA \> 20 * Gleason 8 or higher * Karnofsky performance status ≥ 70. * Signed study-specific informed consent Exclusion Criteria: \-
Study design
Enrollment target: 208 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-03
Estimated completion: 2027-03
Last updated: 2024-12-04
Primary outcomes
  • Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion. (recruitment over 4 years)
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital · other
Contacts & investigators
ContactAshley Feng, M.Sc. · contact · yanqi.feng.ccomtl@ssss.gouv.qc.ca · 514-340-8222
All locations (9)
CIUSSS du Saguenay-Lac-St-Jean/CSSS de ChicoutimiRecruiting
Chicoutimi, Quebec, Canada
CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyneRecruiting
Greenfield Park, Quebec, Canada
CISSS de Laval - Hôpital de la Cité-de-la-santé de LavalRecruiting
Laval, Quebec, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-RosemontRecruiting
Montreal, Quebec, Canada
Jewish General Hospital, McGill UniversityRecruiting
Montreal, Quebec, Canada
MUHC - Cedars Cancer CenterRecruiting
Montreal, Quebec, Canada
CHU - L'Hôtel-Dieu de QuébecRecruiting
Québec, Quebec, Canada
CIUSSS de l'Estrie - Hôpital FleurimontNot Yet Recruiting
Sherbrooke, Quebec, Canada
CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-RivièresRecruiting
Trois-Rivières, Quebec, Canada
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 · TrialPath