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

Sir Mortimer B. Davis - Jewish General Hospital

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02573636

PCS VIII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria