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Proteomic Profiling + Biomarker Testing for Prostate Cancer

N/A

Waitlist Available

Led By Paul Tempst, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care at specific sites

Patient must be able to attend the pre-biopsy blood draw

Timeline

Screening 3 weeks

Treatment Varies

Follow Up conclusion of the study

Awards & highlights

Study Summary

This trial will test if proteomic profiles can help distinguish between men with prostate cancer and those without the disease.

Who is the study for?

This trial is for men aged 18 or older with a PSA level between 2-10 ng/ml, who may have an abnormal rectal exam and are scheduled for a prostate biopsy. They must be able to attend a pre-biopsy blood draw but cannot join if they've had hormone therapy, pelvic radiation, previous prostate cancer diagnosis, or recent alpha-blocker treatment.Check my eligibility

What is being tested?

The study is testing if serum proteomic profiles (protein patterns in the blood) can predict prostate cancer presence. It involves taking blood samples before biopsy and analyzing them using MALDI-TOF MS technology along with other biomarker assays.See study design

What are the potential side effects?

Since this trial involves only drawing blood for testing without any direct interventions like drugs or invasive procedures, side effects are minimal and mainly include potential discomfort or bruising from the needle used to collect the blood sample.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a prostate biopsy using ultrasound guidance.

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I can go to the clinic for a blood test before my biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ conclusion of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~conclusion of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine if men with prostate cancer have a different proteomic profile than men without cancer. Cancer-free status will be confirmed by a re-biopsy at 6 months to reduce the biopsy false negative rate to less than 5 %.

To determine whether the peptide proteomic profile can improve the predictive ability of known serum biomarkers (PSA (free and total), hK2 and su-PAR) for prostate cancer.

Secondary outcome measures

To assess reproducibility of proteomic profiles over different runs, platforms, and sites.

To determine if Caucasian men and men of African-American descent with and without prostate cancer have different proteomic profiles.

To establish a bank of DNA, serum, and frozen lymphoblastoid cells from these patients for the purpose of enabling genetic investigations in men with a diagnosis of prostate cancer.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients undergoing prostatic biopsyExperimental Treatment1 Intervention

This study will enroll two groups of 250 patients who are to undergo prostatic biopsy as part of their routine medical care because of suspicion of prostate cancer (elevated PSA between 2 and 10 ng/ml, abnormal rectal examination, or both). The first group will contain 250 patients of African-American descent and the second will contain 250 Caucasian men.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER

1,055 Previous Clinical Trials

1,315,795 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,139 Patients Enrolled for Prostate Cancer

State University of New York - Downstate Medical CenterOTHER

66 Previous Clinical Trials

12,099 Total Patients Enrolled

1 Trials studying Prostate Cancer

224 Patients Enrolled for Prostate Cancer

NYU Langone HealthOTHER

1,369 Previous Clinical Trials

840,098 Total Patients Enrolled

24 Trials studying Prostate Cancer

4,770 Patients Enrolled for Prostate Cancer

Media Library

serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays. Clinical Trial Eligibility Overview. Trial Name: NCT00773773 — N/A

Prostate Cancer Research Study Groups: Patients undergoing prostatic biopsy

Prostate Cancer Clinical Trial 2023: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays. Highlights & Side Effects. Trial Name: NCT00773773 — N/A

serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays. 2023 Treatment Timeline for Medical Study. Trial Name: NCT00773773 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patient slots available for this clinical experiment?

"Per the information found on clinicaltrials.gov, this research is not currently recruiting patients - it was initially posted in October 2008 and last updated in November 2022. Notwithstanding this fact, there are 1,321 other medical studies that are actively taking partakers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

2008. "Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00773773.