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Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02070575
Enrollment
200
Registered
2014-02-25
Start date
2014-02-20
Completion date
2023-10-18
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

OTHERblood draw

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

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
profile of a panel of kallikrein related serine proteases in the blood2 yearsof patients that present with biochemical recurrence after radical prostatectomy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026