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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of patients with biochemical failure showing coexistence of PTEN and 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) 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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T3a +
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PSA > 20
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Gleason 8 or higher
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Karnofsky performance status ≥ 70.
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Signed study-specific informed consent
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 2 | CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 3 | CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval | Laval | Quebec | Canada | H7M 3L9 |
| 4 | CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 5 | Jewish General Hospital, McGill University | Montreal | Quebec | Canada | H3T 1E2 |
| 6 | MUHC - Cedars Cancer Center | Montreal | Quebec | Canada | H4A 3J1 |
| 7 | CIUSSS de l'Estrie - Hôpital Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 8 | CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières | Trois-Rivières | Quebec | Canada | G8Z 3R9 |
| 9 | CHU - L'Hôtel-Dieu de Québec | Quebec | Canada | G1R 2J6 |
Sponsors and Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCS VIII