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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

T3a +

PSA > 20

Gleason 8 or higher

Karnofsky performance status ≥ 70.

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
recruitment over 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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