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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070575
• Other study ID #: 14-041
• Status: Completed
• Start date: February 20, 2014
• Est. completion date: October 18, 2023

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Other:
• blood 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	profile of a panel of kallikrein related serine proteases in the blood	of patients that present with biochemical recurrence after radical prostatectomy.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center