A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients
N/A
N/A
Male
Prostate Cancer
Trial Information
A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients
Inclusion Criteria:
- patients with prostate cancer post radical radiation therapy and LHRH agonist treated
in PCSIV clinical trial
- biochemical failure (PSA nadir + 2) or minimum follow-up of 3 years post completion
of hormonal therapy
- high risk group
1. gleason score 8-10
2. PSA ≥ 20 ng/ml
3. T3 or T4
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
number of patients with biochemical failure showing the TMPRSS2-ERG gene fusion and/or PTEN deletion
Outcome Description:
biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy who have either biochemical failure or 3-year post treatment follow-up free of cancer recurrences will be tested for the 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 disease recurrence.
Outcome Time Frame:
recruitment over 2 years
Safety Issue:
No
Authority:
Canada: Health Canada
Study ID:
MP-JGH-10-032
NCT ID:
NCT01350180
Start Date:
September 2010
Completion Date:
Related Keywords:
- Prostate Cancer
- biochemical failure
- hormonal therapy
- Prostatic Neoplasms
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