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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02573636
• Other study ID #: PCS VIII
• Status: Recruiting
• Start date: March 2016
• Est. completion date: March 2025

Study information

• Verified date: October 2020
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Ashley Feng, M.Sc.
• Phone: 514-340-8222
• Email: yanqi.feng.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: March 2025
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• T3a +

• PSA > 20

• Gleason 8 or higher

• Karnofsky performance status = 70.

• Signed study-specific informed consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi	Chicoutimi	Quebec
Canada	CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne	Greenfield Park	Quebec
Canada	CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval	Laval	Quebec
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Jewish General Hospital, McGill University	Montreal	Quebec
Canada	MUHC - Cedars Cancer Center	Montreal	Quebec
Canada	CHU - L'Hôtel-Dieu de Québec	Quebec
Canada	CIUSSS de l'Estrie - Hôpital Fleurimont	Sherbrooke	Quebec
Canada	CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion.	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	recruitment over 4 years