Clinical trial NCT02573636: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 208
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The original slides of 208 patients with informed consent will be reviewed. Patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index.

Brief summary: 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: 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:

-

Primary outcomes:
measure: Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion.
timeFrame: recruitment over 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne
state: Quebec
city: Laval
country: Canada
facility: CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital, McGill University
state: Quebec
city: Montreal
country: Canada
facility: MUHC - Cedars Cancer Center
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - Hôpital Fleurimont
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières
state: Quebec
city: Quebec
country: Canada
facility: CHU - L'Hôtel-Dieu de Québec
Study officials:
References: