Prostate Cancer
Conditions
Keywords
PSA, Human Kallikrein 2, locally resected prostate cancer, biochemical recurrence, 14-041
Brief summary
The purpose of this study is to investigate if a new blood test looking at PSA and a group of PSA related proteins in a patient's blood can indicate which men after surgery with a rising PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence before initial treatment is given.
Interventions
Venous blood will be collected in an EDTA Vacutainer tubeup to 10 mL and will be immediately put on ice. This sample may be drawn as a stand-alone blood draw. Samples will be centrifuged at 1900g (3000-3200 RPM) for 15 Minutes and the serum aliquoted into freezer vials and stored at -80°C until analysis. In addition patients who have not received treatment for biochemical recurrence after their first draw are eligible for subsequent draws to determine the reproducibility of the test over time.
Sponsors
Study design
Eligibility
Inclusion criteria
* All patients treated with radical prostatectomy that develop a rising serum PSA ≥ 0.05ng/ml and have not received any kind of additional therapy. * Patients who have had additional therapy post radical prostatectomy are eligible for this study if ≥1 year has passed since treatment and the patient develops a rising serum PSA ≥0.05ng/ml.
Exclusion criteria
* Previous additional therapy for prostate cancer, less than 1 year ago * No evidence of rising PSA * Patients unwilling to undergo venesection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| profile of a panel of kallikrein related serine proteases in the blood | 2 years | of patients that present with biochemical recurrence after radical prostatectomy. |
Countries
United States