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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT02070575

14-041

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Pts with prostate cancer

Description:

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.

Treatment:

Other: blood draw