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

NCT02070575 | Completed

• 1 other identifier: 14-041
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

PSA; Human Kallikrein 2; locally resected prostate cancer; biochemical recurrence; 14-041

Outcome Measures

Primary Outcomes (1)

• profile of a panel of kallikrein related serine proteases in the blood

  of patients that present with biochemical recurrence after radical prostatectomy.

  2 years

Study Arms (1)

Pts with prostate cancer

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.

Other: blood draw

Interventions

blood draw OTHER

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.

Pts with prostate cancer

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vincent Laudone, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 20, 2014
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)