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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: blood draw

• Registration Number: NCT02070575
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-20
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Status Verified: 2023-10
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-18
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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.

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Exclusion Criteria

• Previous additional therapy for prostate cancer, less than 1 year ago
• No evidence of rising PSA
• Patients unwilling to undergo venesection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts with prostate cancer	blood draw	This study is planned to determine the kallikrein panel of 200 patients presenting with biochemical recurrence (PSA ≥ 0.05ng/ml) after radical prostatectomy prior to any additional therapy or minimum post 1 year additional therapy.

Primary Outcome Measures

Name	Time	Method
profile of a panel of kallikrein related serine proteases in the blood	2 years	of patients that present with biochemical recurrence after radical prostatectomy.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States